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ISSN (Online): 0975-8232,
ISSN (Print): 2320-5148

International Journal Of
Pharmaceutical Sciences And Research

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AN UPDATED REVIEW ON ANALYTICAL METHODS FOR THE AZELNIDIPINE AND TELMISARTAN IN PHARMACEUTICAL DOSAGE FORM

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AN UPDATED REVIEW ON ANALYTICAL METHODS FOR THE AZELNIDIPINE AND TELMISARTAN IN PHARMACEUTICAL DOSAGE FORM

Priya Bavishi, Puja Bhavsar *, Lima Patel and Zanza Patel

Department of Pharmaceutical Quality Assurance, Parul Institute of Pharmacy, Parul University, P.O Limda, Vadodara, Gujarat, India.

ABSTRACT: Hypertension, also known as high blood pressure, occurs when the force of blood against the artery walls is excessively high the force of blood against the artery wall is too high. Hypertension is a very common disorder, particularly in past middle age. For improvement activity of hypertension, Azelnidipine and Telmisartan are newer combination in the market which is effective in hypertension. This combination was developed to improve medication for stage II hypertension. Azelnidipine is a Calcium channel blocker, and Telmisartan is an Angiotensin II receptor blocker. This review provides information about different analytical methods for estimating Azelnidipine and Telmisartan individually or in combination with other drugs, such as UV spectrophotometry, HPTLC, HPLC, and LC-MS. All reported methods were found to be simple, accurate, economical, precise, and reproducible. This review focuses on the recent analytical method development of Azelnidipine and Telmisartan in their combined dosage form. It also includes a stability-indicating analytical method for determining Azelnidipine and Telmisartan.

Keywords: Analytical Method, Azelnidipine, High Performance Liquid Chromatography, High Performance Thin Layer Chromatography, Telmisartan, Ultraviolet Spectroscopy

INTRODUCTION: Azelnidipine is a dihydropyridine calcium channel blocker. Azelnidipine is L and T calcium channel blocker. It is sold in Japan by Daiichi-Sankyo Pharmaceuticals, Inc. Unlike nicardipine; it has a gradual onset and a long-lasting hypoglycaemic effect, with little increase in heart rate. The Drug Controller General of India (DCGI) has approved the use of Azelnipine in India. It was launched under the Azusa (Ajanta Pharma Ltd.) brand in 2020 1.

Mechanism of Action of Azelnidipine: Azelnidipine inhibits trans-membrane Calcium influx through the voltage-dependent channels of smooth muscles in vascular walls. Calcium channels are classified into various categories, including L-type, T-type, N-type, P/Q-type, and R-type Calcium channels. Normally, calcium induces smooth muscle contraction, contributing to hypertension. When calcium channels are blocked, the vascular smooth muscle does not contract, resulting in the relaxation of vascular smooth muscle walls and decreased blood pressure 2.

Telmisartan: Telmisartan, sold under the brand name Micardis among others, is a medication that is widely prescribed for the treatment of high blood pressure, heart failure, and diabetic kidney disease. It is considered to be a reasonable initial treatment option for individuals with high blood pressure, and it is typically administered orally. In addition to the standalone form, Telmisartan is available in combination with hydrochlorothiazide, cilnidipine, and amlodipine. It is worth noting that Telmisartan stands out from other drugs in its class due to its relatively high average dosage of 80 mg/day.

Mechanism of Action of Telmisartan: Telmisartan is an angiotensin II receptor blocker (ARB). It works by blocking a substance in the body that causes blood vessels to tighten. As a result, telmisartan relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart 4.

Physical and Chemical Property: Azelnidipine is light yellow to yellow crystalline powder. IUPAC name is 3-[1- (Benzyldrylazetidin-3-yl] 5-isopropyl- 2- amino6methyl-4-(3-nitrophenyl)-1,4- dihydropyridine-3, 5dicarboxylate. The molecular formula of Azelnidipine is C₃₃H₃₄N₄O₆. Molecular weight is 582.646 g/mol. It is insoluble in water, slightly soluble in methanol, soluble in ethyl acetate, freely soluble in acetone, and in acetic acid 5.

Telmisartan is white to off-white crystalline powder. IUPAC name is 2-(4-[[4-methyl-6-(1- methylbenzimidazol-2yl)-2 –propylbenzimidazol-1yl] methyl] biphenyl)-benzoic acid. Molecular formula of Telmisartan C₃₃H₃₀N₄O₂. Molecular weight is 514.6 g/mol It is insoluble in water, sparingly soluble in dichloromethane, strong acid, and organic solvents and soluble in strong base and methanol 6.

FIG. 1: CHEMICAL STRUCTURE OF AZELNIDIPINE 7  

FIG. 2: CHEMICAL STRUCTURE OF TELMISARTAN 8

TABLE 1: OFFICIAL METHOD FOR ASSESSMENT OF AZELNIDIPINE

Sr. no. Official In Method Description
1. Indian Pharmacopoeia (2018) 9 Liquid Chromatography Column: Octadecylsilane Silica (25cm x 4.6 mm,5µ

Mobile phase: 0.03 M potassium dihydrogen orthophosphate in water:  Acetonitrile (50:50) v/v

Wavelength: 256 nm

Flow rate: 1.0 ml/min Injection volume :20 µL

TABLE 2: REPORTED METHODS FOR ASSESSMENT OF AZELNIDIPINE

Sr. no. Title/Method Description
1. Validated Stability-Indicating RP-HPLC Method for the Simultaneous Determination of Azelnidipine and Olmesartan in their Combined Dosage Form10. Column: Hypersil GOLD C18 (150 mm × 4.6mm, 5 µm)

Mobile Phase: Methanol: Acetonitrile: Water (40:40:20) v/v/v Flow rate: 0.5 mL/min

Wavelength :260 nm

Linearity: AZL – 2 - 48 μg/ml OLM- 2.5 - 60 μg/ml

Retention Time: AZL -8.56min. OLM - 3.04 min
2. UV Spectrophotometric method development and Validation for Determination of Azelnidipine in Pharmaceutical Dosage Form11. Model: Shimadzu 1800 UV Visible spectrophotometer

Solvent: Methanol

Wavelength (nm): 255nm

Linearity: 2 - 14 µg/ ml
3. Validation and Forced Stability- Indicating HPTLC Method For Determination of Azelnidipine12. Stationary Phase: Silica gel 60 F254 (20cm × 10cm, 0.2mm)

Mobile Phase: Chloroform: Ethyl acetate: methanol 6.5:3.5: 0.1 (v/v/v)

Wavelength: 255nm

Linearity: 300-800ng/band

Rf Value: 0.59,0.60
4. Simultaneous Determination of Azelnidipine and Olmesartan medoxomil by First Derivative Spectrophotometric Method13. Model: Shimadzu – 1800 UV Visible Spectrophotometer

Solvent: Methanol

Method: 1. First Derivative Spectrophotometric method

Wavelength (nm): AZL - 217nm OLM- 239.4 nm

Linearity: 4 - 32 µg/ ml
5. Spectrophotometric estimation of Azelnidipine in Bulk and Pharmaceutical dosage form by second order derivative methods14. Model: Shimadzu 1800 UV Visible Spectrophotometer

Solvent: Methanol

Method: 1. Second Derivative Spectrophotometric method

Wavelength: 233.8 nm

Linearity: 1 - 20 µg / ml
6. Method Development and Validation of Azelnidipine by RP-HPLC15. Column: C18 column (250 mm x 4.5 mm, 5 μm)

Mobile Phase: Methanol: Water (75:25) v/v,0.1%glacial acetic acid.

Flow rate: 1 mL/min

Wavelength: 254nm

Linearity: 10 - 50 μg/ml

Retention Time: 6.13 min.
7. RP-HPLC Method Development and Validation of Azelnidipine16. Column: C18 column (250 mm x 4.5 mm, 5μm)

Mobile Phase: Methanol: Water (80:20) v/v, Orthophosphoric acid (pH-3)

Flow rate:1 mL/min.

Wavelength:257 nm

Linearity:20-100μg/ml

Retention Time: 6.5 min.
8. Sensitive Analysis of Azelnidipine and Related Derivative in Human Plasma by Ultra-Performance Liquid Chromatography-Tandam Mass Spectrometry17. Column: C18 (50 mm × 2.1 mm.,1.7 µm)

Mobile Phase: A (20 mm Ammonium acetate aqueous solution) B (0.1 % formic acid in Acetonitrile)

Flow Rate: 0.5 mL/min

Linearity: 0.01-10 mg/ml

Retention Time: AZL -1.38 min. IS -1.26 min.
9. Simultaneous determination of Azelnidipine and two metabolites in Human Plasma using Liquid chromatography-tandem mass spectrometry18. Column: Intersil ODS-3 C18 (2.1 mm × 150 mm,5μm)

Mobile Phase: Methanol: Water: Acetic Acid (800:200:0.2) v/v

Flow rate: 0.2ml/min.

Wavelength: 256nm

Linearity: 0.5-40 mg/ml

Retention Time: AZL –3.6min. M-1(Aeromatized form)-10.2min. M-2(Hydroxylated Form)-6.8min.
10. Stability Indicating Analytical Method Development and Validation for Estimation of Azelnidipine19. UV Spectrophotometric method: Solvent: Methanol: Water (80:20) v/v Method 1- Zero order Spectrophotometric method

Method 2 -First order Derivative Spectrophotometric method Wavelength: Method 1 -257 nm Method 2- 242.6 nm

Linearity: 2-10μg/ml

Method 3 – RP HPLC Method

Column: ODS C18 (250mm×4.6mm.,5μm)

Mobile phase: Sodium dibasic Phosphate Buffer: Acetonitrile: Methanol (10:50:40) v/v/v, orthophosphoric acid (pH - 4.5)

Flow rate: 1mL/min, Wavelength: Method 3 -256nm, Linearity: 2-12μg/m l Retention Time: 6.1 min.
11. Simultaneous Determination of Azelnidipine and Olmesartan Medoxomil in Pharmaceutical Dosage Forms by UFLC Method20. Column: ODS (250mm x 4.6mm, 5μm)

Mobile Phase: Methanol: Water (85:15) v/v

Flow Rate: 1.5ml/min.

Wavelength: 255nm

Linearity: 2-16 mg/ml

Retention Time: AZL - 6.80 min. OLM -1.72 min.
12. Analytical method development and Validation of Azelnidipine by UV-visible spectroscopy21.

 

 Double Beam UV- visible spectrophotometer with 1.0cm matching quartz

Wavelength: 200‐400 nm

Solvent: Distilled grade water Methanol
13. Development and Validation of RP-HPLC method for quantification of Azelnidipine in tablet22.

 

 Column: Luna C18 (150 x 4.6mm, 5µm)

Mobile phase: Acetonitrile: Water (90:10)

Flowrate: 1ml/min

Wavelength: 255nm

Injection volume: 20µl

Retention time- 3.5 min

Run time- 10 min
14. Development and Validation of Stability Indicating RP-HPLC Method for Azelnidipine for bulk drug23.

 

 Column: Phenomenex Hyper Clone C18 column (250 × 4.6 mm, 5µm)

Mobilephase: methanol: water 75:25% v/v

Flow rate: 1ml/min

Wavelength: 256nm

Retention time- 3.5 min

Run time- 10 min
15. Stability-Indicating LC Method for Quantification of Azelnidipine: Synthesis and Characterization of Oxidative Degradation Product24.

 

 Mobile phase: phosphate buffer (pH 3.0) methanol 10:90% v/v

Flow rate: 1.0 mL/min

Wavelength: 256 nm
16. Mathematically Processed UV Spectroscopic Method for Quantification of Chlorthalidone and Azelnidipine in Bulk and Formulation25.

 

 Model: UV spectrophotometer (1650, Shimadzu, Japan)

Wavelength: 238.5 nm and 239.5 nm for CTL and 272.1 nm and 342.1 nm for AZE, respectively

Solvent: Absolute ethyl alcohol (ethanol)
17 Special Emphasis on Bio-analytical Method development and Validation of an Anti-Hypertensive Drug Azelnidipine by LC-ESI-MS/MS in Healthy Human Volunteer’s Blood Plasma26. Column: C18 Phenomenex Kinetex (50x3mm, 5µ)

Mobilephase: 0.1% Formic Acid in Acetonitrile and Milli-Q water with 10mM Ammonium acetate

Flow rate: 0.5 ml/min

Retention time- 3.5 min

Injection Volume- 10 µl

Run time- 7 min

TABLE 3: OFFICIAL METHOD FOR ASSESSMENT OF TELMISARTAN

Sr. no. Official In Method Description
1. Indian Pharmacopoeia (2018)27 Liquid Chromatography Stationary Phase: A stainless steel Column 12.5 cm×4mm, packed with octadecylsilane bonded to porous silica (5 µm)

Mobile Phase: A) Dissolve 2.0 g of Potassium Dihydrogen Phosphate and 3.8g of Sodium Pentane sulphonate monohydrate in water, adjust to pH 3 with orthophosphoric acid dilute to 1000ml with water. B) A Mixture of 20 Volume of Methanol and 80 Volume of Acetonitrile. (20 :80) v/v

Flow rate: 1ml/min.

Wavelength: 230nm

Injection Volume: 10µL

TABLE 4: REPORTED METHODS FOR ASSESSMENT OF TELMISARTAN

Sr. no. Title/Method Description
1. RP-HPLC Method Development and Validation for estimation of Telmisartan in bulk and tablet dosage form28. Column: RP18, column (250×4.6mm)

Mobile phase: 0.025M potassium dihydrogenphosphate: acetonitrile: methanol (45:50:5)

Flow rate: 1ml/min

Wavelength: 216 nm
2. Method development and validation of Telmisartan in bulk and pharmaceutical dosage forms by UV spectrophotometric method29. Model: Shimadzu, model 1700

Wavelength: 298nm

Solvent: Methanol: Water (90: 10)
3. UV-spectrophotometric analytical method development and Validation for determination of Telmisartan in pharmaceutical drug and drug product30. Model: U.V. visible double beam spectrophotometers SL210 Elico

Wavelength:  200-400 nm

Solvent:Water and Methanol
4. Stability Indicating assay of Telmisartan in tablets31. Column:  Kromasil C18 (4.6 × 150 mm, 5 µm)

Mobile phase:  0.01 M Phosphate buffer (pH: 3) and Acetonitrile in ratio of (40:60%)

Flow rate: 2ml/min

Wavelength: 226 nm

Retention time- 2.728 min
5. Stress degradation studies on Telmisartan and development of a validated method by UV spectrophotometry in bulk and pharmaceutical dosage forms32. Model: A double beam UV-Visible spectrophotometer (Shimadzu-1800) with UV probe 2.31 software

Wavelength:200–380nm

Solvent: Methanol
6. Determination of Telmisartan by HPTLC – A Stability Indicating Assay33. Mobile phase: chloroform–methanol 8.6:1.4 (v/v) containing 0.1% ammonia

HPTLC plate: 10 cm × 20 cm aluminum-backed

Wavelength: 297 nm

Scanning speed: 5 mm s–1

Source of radiation: deuterium lamp
7. Stability Indicating HPLC method for the determination of Telmisartanas bulk drug and in pharmaceutical dosage form34. Model:  M/S Shimadzu HPLC system with a photodiode array detector system (SPD – M20A)

Column: Phenomenex luna ODS, (25 cm x 4.6 mm OD, 5µ, pore size 100A°)

Mobile phase: phosphate buffer and acetonitrile 60: 40

Flow rate: 1.5ml/min

Wavelength: 230 nm

Retention time: 2.728 min

Run time: 30 minutes
8. Stability-Indicating RP-HPLC Method for Analysis of Telmisartanin the Bulk Drug and in Formulations35. Model: Jasco model PU 1580, intelligent HPLC pump, an AS-1555 sampler with auto injecting facility

Column: C18 column

Mobile phase: Methanol: Water 80:20 (v/v)

Flow rate: 1.0ml/min

Wavelength: 225 nm

Retention time: 4.85 ± 0.05 min
9. Stability Indicating HPTLC method for simultaneous determination of Telmisartan and Ramipril in tablets36. HPTLC plates: (Merck) precoated with silica gel 60F254 aluminium sheets

Mobile phase: toluene: acetonitrile: formic acid: water (5:5:0.3:1)

Wavelength: 212 nm
10. Development and Validation of Stability Indicating HPTLC and HPLC Methods for Simultaneous Determination of Telmisartan and Atorvastatin in their Formulations37. For RP-HPLC:

Column: Phenomenex Luna C18

Mobile phase:  acetonitrile: 0.025 M ammonium acetate (38: 52%, v/v)

Flow rate: 1.0ml/min

Wavelength: 281 nm

For HPTLC:

HPTLC plates: Silica gel 60 F254

Mobile phase: toluene-methanol-ethyl acetate-acetic acid (5: 1: 1: 0.3, v/v)

Wavelength: 279 nm
11. A validated stability indicating HPTLC method for simultaneous estimation of Ramipril and Telmisartan38. HPTLC plates: TLC plate precoated with Silica gel 60 F254

Mobile phase: Methanol: Chloroform (1:6) v/v

Wavelength: 210 nm
12. Development and Validation of stability-indicating HPTLC method for simultaneous determination of Telmisartan and Cilnidipine in combined tablet dosage form39. HPTLC plates: Precoated silica gel aluminium plate 60 F254(10 ×10) with 250μm thickness

Mobile phase: Toluene: Methanol: Glacial acetic acid (8: 2: 1, v/v/v)

Wavelength: 260 nm

Retention factor: Telmisartan 0.38 ± 0.004 and cilnidipine 0.62 ± 0.007
13. Stability-Indicating RP-HPLC method development and Validation for simultaneous estimation of Telmisartan and Rosuvastatin calcium in bulk and in tablet dosage form40. Column: Oyster ODS3 (150 × 4.6 mm,5 µm)

Mobile phase: phosphate buffer with 1.1 g octane-1-sulfonic acid sodium salt having pH 2.5 and acetonitrile, with a proportion of 500:500, v/v

Flow rate:  1.0 mL/min
14. Stability-Indicating HPLC method for simultaneous estimation of low-level impurities of Telmisartan and Hydrochlorothiazide in tablet dosage forms41. Column: Inertsil ODS 3V (250 x 4.6 mm, 5μm)

Flow rate: 1.3 mL/min

Wavelength: 260 nm

Buffer: 1 % (v/v) triethylamine in potassium hydrogen orthophosphate (pH 2.5) and acetonitrile buffer
15. Stability indicating reverse-phase high-performance liquid chromatography method development and Validation for simultaneous estimation of Telmisartan and Benidipine hydrochloride in pharmaceutical dosage form42. Column: C18, 250×4.6 mm column of 5.0μm particle packing

Flow rate:  1.0 mL/min

Wavelength: 210nm

Detector: photodiode array
16. Stability Indicating Simultaneous Validation of Telmisartan and Cilnidipine with Forced Degradation Behavior Study by RP-HPLC in Tablet Dosage Form43. Column: C18 250×4.6mm, 5 μm

Mobile phase: Acetonitrile (ACN): buffer pH 3.0 with Orthophosphoric acid (68: 32)

Flow rate:  1.0 mL/min

Wavelength: 245nm

Detector: photodiode array
17. RP-HPLC Estimation of Ramipril and Telmisartan in Tablets44. Column: C18 column having dimensions of 4.6×250 mm and particle size of 5μm

Mobile phase: 0.01 M potassium dihydrogen phosphate buffer (adjusted to pH 3.4 using orthophosphoric acid): methanol: acetonitrile (15:15:70 v/v/v)

Flow rate: 1.0 mL/min

Wavelength: 210nm

Retention Time:  ramipril (Rt: 3.68 min) and telmisartan (Rt: 4.98 min)
18. Development and Validation of RP-HPLC Method for simultaneous estimation of Telmisartan, Amlodipine Besylate, and Hydrochlorothiazide in their tablet dosage form 45. Column: C18 kinetex column (250 × 4.6 mm, 5 µ)

Mobile phase: Acetonitrile: 20mM phosphate buffer (pH 3.0) (60:40 %, v/v)

Flow rate:  1.0 mL/min

Wavelength: 258nm
19. Development And Validation of a Stability Indicating RP-HPLC Method For Simultaneous Determination of Telmisartan and Amlodipine in Combined Dosage form46. Column: Hypersil BDS C18 Column (100 mm x 4.6 mm, 5µ.)

Mobile Phase: Phosphate Buffer (pH 3.6): Acetonitrile (60:40) v/v

Flow rate: 1 mL/min.

Wavelength: 234 nm

Linearity: TEL -10–150µg/ml AMLB -1–20 µg/ml

Retention Time: TEL – 4.1 min. AMLB– 2.6 min.
20. Stability-Indicating RP-UHPLC Method For Determination of Telmisartan in Drug Substance and Marketed Formulation47. Column: Poroshell 120EC-C18 column (4.6 x 50mm, 2.7µm)

Mobile Phase: Acetonitrile: 50mM ammonium acetate buffer (45:55) v/v, (pH 4.5) acetic acid.

Flow rate: 1ml/min.

Wavelength: 290 nm
21. Development and Validation of Analytical Method for Simultaneous Estimation of Bisoprolol Fumarate and Telmisartan by Using RP HPLC Method48. Column: Waters X Bridge RP C18(250mm x 4.6 mm,5 µm)

Mobile Phase: Methanol and water (75:25 v/v)

Flow Rate: 1ml/min.

Wavelength: 231nm

Linearity: BIS:5-25μg/ml TEL: 40-200μg/ml

Retention Time: BIS-5.7 min. TEL -7.6min.
22. A New RP-HPLC method for simultaneous estimation of Telmisartan and Cilostazol in the synthetic mixture49. Column: C18G (250 mm × 4.6 mm, 5 µm)

Mobile Phase: Potassium dihydrogen phosphate buffer (10mM): Methanol: Acetonitrile (30:10:60) v/v/v (pH 5.8)

Flow rate: 1.0 mL/min.

Wavelength: 257 nm

Linearity: TEL -2-10 µg/ml, CIL- 4-20 µg/ml

Retention Time: TEL: 9.6 min. CI L: 5.49 min.
23. Method Development and Validation for Simultaneous Estimation of Telmisartan and Chlorthalidone by RP-HPLC in Pharmaceutical Dosage Form50. Column: CAPCELL C18 (250mm×4.6mm, 5µm)

Mobile Phase: Potassium di hydrogen ortho phosphate buffer: Acetonitrile: Methanol (35:45:20) v/v/v (pH 3.5) Ortho phospheric acid

Flow Rate:0.8 mL/min.

Wavelength:296nm

Linearity: TEL -20- 100µg/mL, CHLT: 6.25-31.25 µg/mL

Retention Time: TEL- 4.97 min. CHLT: 3.46 min.
24. Development and Validation RP-HPLC Method for Simultaneous Estimation of Telmisartan and Nifedipine in Synthetic Mixture51. Column: Phenomenex Luna C18(250mm×4.6mm,5m)

Mobile Phase: ACN: Water: Methanol (10:20:70 v/v/v) pH 3.8

Wavelength: 234 nm

Flow rate: 1 ml/min

Linearity: TEL: 4-20 𝜇g/ml, NIF: 2-10 𝜇g/ml

Retention Time: TEL: 2.563 min NIF: 4.403 min
25. Development and Validation of Rapid RP-HPLC Method for the Detection and Quantification of Telmisartan Incorporated in Dosage Forms and Plasma52. Column: C18 column (4.6 mm×250 mm, 5 µm)

Mobile Phase: Acetonitrile: Methanol: 0.01 M sodium dihydrogen orthophosphate (41:10:49) v/v/v (pH 3.0) Orthophosphoric acid

Wavelength: 291 nm

Flow rate: 0.8 mL/min

Linearity: 0.1-10µg/ml

Retention Time: 2.4 min.
26. A Validated RP-HPLC Method for Tablets Containing Amlodipine Besylate and Telmisartan HCl as Active Pharmaceutical Ingredient53. Column: Phenomenix C18 (250 mm × 4.6 mm, 5 µm)

Mobile Phase: 0.02M Ammonium Phosphate buffer: Acetonitrile: Methanol (40:35:25) v/v/v

Flow rate: 1.0mL/min.

Wavelength: 254nm: TEL – 0.8 -160 µg/ml AMLB – 0.1-2 µg/ml

Retention Time: TEL -2.65 min. AMLB – 4.996 min.
27. Analytical Method Development and Validation for The Simultaneous Estimation of Metformin and Telmisartan in Bulk and Pharmaceutical Dosage Forms Using RP-HPLC Method54. Column: BDS (250mm x 4.6 mm, 5 m)

Mobile Phase:  Buffer: Acetonitrile: Methanol (35:55:10) v/v/v

Flow rate: 1mL/min

Wavelength: 237nm

Linearity: MET: 5-30µg/ml TEL: 62.5-375µg/ml

Retention Time: MET- 2.4 min. TEL-3.2 min.
28. Development and Validation of Bioanalytical HPLC Method For Estimation of Telmisartan in Rat Plasma: Application to Pharmacokinetic Studies55. Column: Phenomenex Luna® C8 (300mm× 4.6 mm,5m)

Mobile Phase: Methanol: Acetonitrile (70:30 (v/v)

Flow rate: 1 ml/min

Wavelength: 190-800 nm

Linearity: 10 - 1000 µg/ml

Retention Time: 2.3 min.
29. Analytical Method Development and Validation for the Simultaneous Estimation of Telmisartan and Atorvastatin in Bulk and Tablet Dosage Form56. Column: Inertsil-ODS C18 (250mm×4.6mm,5m)

Mobile Phase: Methanol:water(50:50) v/v

Wavelength: 250 nm

Flow rate:1mL/min

Linearity: 20 to 80 µg/ml

Retention Time: TEL -2.4 min. ATC – 3 min.
30. Development and Validation of HPTLC Method for Simultaneous Estimation of Amlodipine Besylate, Hydrochlorothiazide and Telmisartan in Their Combined tablet dosage form57. Stationary phase: pre-coated with silica gel 60F254(10×10 cm)

Mobile Phase: Chloroform: Butanol: Ammonia (6: 4: 0.1) v/v/v

Flow Rate: 1 mL /min.

Wavelength: AML- 237.5 nm, HCTZ - 270 nm, TLM- 297nm

Retention Time: AML – 3.2 min. HCTZ – 3.1 min. TEL – 3.5 min.
31. Simultaneous Estimation of Telmisartan and Atorvastatin calcium in API and tablet dosage form58. Column: Boston ODS C18 (250mm x 4.6 mm, 5 µ)

Mobile Phase: Methanol:  Acetonitrile:  buffer (35:25:40) v/v

Flow rate: 1.0mL/min.

Wavelength: 235nm

Linearity: 60-140µg/ml

Retention Time: TEL -3.5 min. ATC -2.3 min.
32. A Fast and Validated Reversed-Phase HPLC Method for Simultaneous Determination of Simvastatin, Atorvastatin, Telmisartan and Irbesartan in Bulk Drugs and Tablet Formulations59. Column: C18 (75 mm × 4.6 mm ,3.5 µ)

Mobile Phase: Ammonium acetate buffer (10 mM (pH 4.0): Acetonitrile (40:60) v/v

Flow rate: 1mL/min

Linearity: 1–16 µg/mL

Wavelength: 220nm

Retention Time: IRB – 1.20 min. ATV – 1.82 min. TLM – 2.40 min. SMV – 6.03 min.
33. Analytical Method Development and Validation of First Order Derivative Spectrophotometric Method for Simultaneous Estimation of Telmisartan and Metformin Hydrochloride in their Combined Pharmaceutical Dosage Form60. Model: Shimadzu model1700

Diluents: Methanol: Water (50: 50) v/v

Method: First Order Derivative

Linearity: TEL- 6-16 µg/mL MET- 6-16 µg/mL

Wavelength: TEL- 251 nm MET- 217 nm
34. QbD-based development of HPLC method for simultaneous quantification of Telmisartan and Hydrochlorothiazide impurities in tablets dosage form61. Column: Kromosil C18(125mm× 4.0 mm, 5 μm), Inertsil ODSV (150 mm 4.6 mm, 3.5 μm)

Mobile Phase:

Solvent A: Potassium dihydrogen phosphate buffer, (pH 3.5) 1%Ortho phosphoric acid solution

Solvent B: Purified water and acetonitrile (100:900) v/v

Flow rate: 1.0 mL/min.

Wavelength: 230 nm

Linearity: TEL -1.5 μg/mL HCZ - 0.6 μg/ml

Retention Time: 3.2 min.
35. Method Development and Validation of Simultaneous Estimation of Cilostazol and Telmisartan62. Model: Shimadzu model 1700 double beam UV-Visible spectrophotometer S

solvent: Methanol

Methods: 1. Simultaneous Equation method 2. Absorbance Ratio method

Wavelength: TEL- 258 nm, 237.5 nm CLZ– 258 nm, 237.5nm

Linearity: TEL-1 -5 µg/ml CLZ - 4-20 µg/ml
36. RP-HPLC method for estimation of Telmisartan in human plasma63. Column: HibarC18 (250 mm x 4.6 mm ,5 μm)

Mobile Phase: Ammonium Formate solution (pH 4.0): Methanol (70:30), v/v

Flow Rate: 1 mL/min

Wavelength: 275 nm

Linearity: 0.1-1.5 (µg/ml)

Retention Time: 3.7 min.
37. Development and Validation of RP-HPLC Method for Estimation of Telmisartan in Bulk and Tablet Dosage Form64. Column: C18 sun fire column (250mmx4.6mm,5µm)

Mobile Phase: Potassium di-hydrogen Phosphate: Acetonitrile (60:40) v/v

Flow Rate: 1mL/min

Wavelength:243nm

Linearity: 50 -150 µg/ml

Retention Time: 3.4 min.
38. Analytical Method Development and Validation for the Simultaneous Estimation of Telmisartan and Hydrochlorthiazide by RP HPLC method in Bulk and Tablet Dosage Form65. Column: Agilent C18 (4.6 mm×150mm,5µ)

Mobile Phase: Methanol: Acetonitrile (70: 30) v/v

Flow rate: 1ml/min

Wavelength: 240nm

Linearity: TEL: 15- 55µg/ml HCTZ :50 -250µg/ml

Retention Time: TEL-1.8min. HCTZ-2.4min.
39. Development and Validation of UV Visible Spectrophotometric Method for Estimation of Cilnidipine and Telmisartan in Bulk and Dosage Form66. Model: Shimadzu UV/Visible double beam spectrophotometer (Model 1700)

Solvent: Acetonitrile

Wavelength: TEL -241nm CIL - 203nm

Linearity: TEL -0.5-2.5 µg/ml CIL - 2-10µg/ml
40. UV Spectrophotometric method development and Validation for Telmisartan in Bulk and Tablet Dosage Form67. Model: Shimadzu UV- 1700

Solvent: 0.1 N NaOH, Distilled water

Wavelength: 234nm

Linearity: 2-10 µg/ml
41. Dissolution Method Development and Validation for Tablet Dosage form of Telmisartan Using UV Spectrophotometric Method68 Model: Double beam UV visible spectrophotometer Shimadzu UV 1800

Diluent: Methanol

Wavelength:296nm

Linearity: 2-12µg/ml
42. UV-Spectrophotometric Determination for Simultaneous Estimation of Amlodipine Besylate and Telmisartan in Combination69 Model: UVA 1002 E

Solvent: 0.1 N HCL

Method: 1. Absorbance correction method,

2. Absorbance ratio Method

Wavelength: TELM –292 nm AMLB- 326 nm

Linearity:

Method 1. – Absorbance correction method TEL - 3-24 µg/ml AMLB - 0.5-20 µg/ml

Method 2. - Absorbance ratio Method TEL- 3-24 µg/ml AMLB- 0.5-15.5 µg/ml
43. Development of UV spectrophotometric method for estimation and Validation of Telmisartan as a pure API70 Model: Shimadzu UV1800 UV-Visible double beam spectrophotometer

Solvents: Ethanol (95%), 0.1 N NaHCO3

Wavelength: 240nm

Linearity: 2-14 µg/ml
44. Absorbance correction method for estimation of Telmisartan and Metoprolol succinate in combined tablet dosage forms71 Model: UV-Visible double beam spectrophotometer Shimadzu UV1800

Solvent: Methanol

Method: Absorbance correction method

Wavelength: TEL - 296nm MET - 223nm

Linearity: TELM - 2-16 µg/ml MET- 3 -24 µg/ml
45. Development and Validation of a Solvent Extraction UV Spectrophotometric Method for the Estimation of Rosuvastatin Calcium and Telmisartan in Combined Dosage Form72 Model: UV-Visible double beam spectrophotometer Shimadzu 1800

Solvents: Telmisartan- methanol and Rosuvastatin Calcium- phosphate buffer pH 5.5

Wavelength: Rosuvastatin Calcium-242.8nm and Telmisartan- 295.2 nm
46. Analytical Method Development and Validation for Telmisartan, Chlorthalidone and Amlodipine by UV- Spectroscopic Method73 Model: JASCO-V-530. UV-Visible Spectrophotometer

Solvents: Methanol

Wavelength: 311nm- Telmisartan, 228nm-Chlorthalidone and 253nm- Amlodipine)

TABLE 5: REPORTED METHODS FOR ASSESSMENT OF AZELNIDIPINE AND TELMISARTAN

Sr. no. Title/Method Description
1. Development of HPLC stability demonstrating methodology for quantifying Azelnidipine and Telmisartan in tablets and bulk74 Column:  250 mm length C18 column (Supelco, 4.6 mm inner diameter, 5.0 μm particle size)

Mobile phase: 0.1M Na2SO4 (pH 3.6) and acetonitrile (55: 45% v/v)

Flow rate:  1.0 mL/min

Wavelength: 258nm

Detector: photodiode array
2. Analytical Method Development and Validation of Azelnidipine and Telmisartan by RP HPLC Method75 Column: C18 (4.6 × 150 mm, 5 mm)

Mobile phase: Buffer 0.01 N KH2PO4: Acetonitrile (45:55 % v/v)

Flow rate:  1.0 mL/min

Wavelength: 290nm

Retention time: Azelnipidine- 2.131 min Telmisartan- 2.593 min
3. Stability Indicating RP-HPLC Method Development and Validation for the Simultaneous Estimation of Telmisartan and Azelnidipine in Tablet Dosage Form76 Column: Hyperchrom ODS C18 Column (250*4.6mm)

Mobile phase: Buffer 0.05M Potassium dihydrogen ortho phosphate Buffer (pH-4.0): Methanol (60:40)

Flow rate: 1.0 mL/min

Wavelength: 215nm

Retention time: Telmisartan- 3.440min Azelnidipine- 5.693min.
4. Telmisartan and Azelnidipine quantification employing HPLC statagram; Stability investigation on Telmisartan and Azelnidipine77 Column: C18 Kromasil stationary column (5 µm, 250 mm × 4.6 mm)

Mobile phase: 0.1M NaH2PO4 solution (pH 3.5) and methanol at a comparative volume ratio of 50% each.

Flow rate: 1.0 mL/min

Wavelength: 256nm
5. A stability indicating RP-HPLC method validation for simultaneous estimation of Azelnidipine and Telmisartan in a fixed-dose combination78 Column: Inertsil C-18 Column with 150×4.6 mm× 5 µm

Mobile phase: Acetonitrile and buffer

Flow rate: 1.5 mL/min

Wavelength: 254nm
6. Development and Validation of UV Spectrophotometric method for the simultaneous estimation of Azelnidipine and Telmisartan in combined dosage form79 Model: JASCO double beam UV-vis spectrophotometers

Wavelength:  200-400 nm

Solvent: Methanol
7 RP-HPLC Method for Determination of Azelnidipine and Telmisartan in Pharmaceutical Dosage Form 80 Column: Intersil C18 column (250 × 4.6mm × 5µm)

Mobile phase: Acetonitrile: 5 millimolar phosphate buffer pH 4.6 (70:30 v/v)

Flow rate: 1mL/min

Wavelength: 255nm
8 Method development and Validation for Simultaneous Quantification of Azelnidipine and Telmisartan in Pharmaceutical dosage form by UV 81. Model: JASCO double beam UV-vis spectrophotometers

Wavelength:  200-400 nm

Solvent: Methanol
9 Analytical method development and validations for simultaneous estimation of antihypertensive drugs 82

 

 Column: C 18 column (250mm x 4.6mm, 5μm)

Mobile phase: A- (0.1% formic acid in water as an aqueous phase) B- (acetonitrile as an organic modifier)

Flow rate: 0.8 ml/min

Wavelength: 260nm

Retention time: Telmisartan- 5.950 min

Azelnidipine: 7.293min

CONCLUSION: This review article presents the Physicochemical properties and Pharmacological actions of Azelnidipine and Telmisartan. The presented review gives information about the various methods reported in the literature for determining Azelnidipine and Telmisartan, including official pharmacopeial assay methods.

This review concluded that different analytical methods are reported for the estimation of Azelnidipine and Telmisartan individually and other combinations like UV Spectroscopy, HPLC, HPTLC, and LC-MS. Hence, all methods were simple, accurate, precise, and reproducible. The Literature review focuses on various UV and HPLC methods reported for Azelnidipine and Telmisartan in fixed-dose combinations. This review will help develop the analytical methods for this new combination and give knowledge about both hypertensive drugs' characteristics.

ACKNOWLEDGEMENT: We wish to acknowledge the Department of Pharmaceutical Quality Assurance at Parul Institute of Pharmacy, Parul University, for their help and constant support in the compilation of the article.

CONFLICTS OF INTEREST: The authors report no conflict of interest. The authors alone are responsible for the content and writing of this article.

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    How to cite this article:

    Bavishi P, Bhavsar P, Patel L and Patel Z: An updated review on analytical methods for the azelnidipine and telmisartan in pharmaceutical dosage form. Int J Pharm Sci & Res 2023; 14(9): 4331-43. doi: 10.13040/IJPSR.0975-8232.14(9).4331-43.

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IJPSR

Priya Bavishi, Puja Bhavsar *, Lima Patel and Zanza Patel

Department of Pharmaceutical Quality Assurance, Parul Institute of Pharmacy, Parul University, P.O Limda, Vadodara, Gujarat, India.

puja.bhavsar16123@paruluniversity.ac.in

23 December 2022

20 March 2023

30 May 2023

10.13040/IJPSR.0975-8232.14(9).4331-43

01 September 2023

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