ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF TERTIARY COMBINATIONS OF ANTIHYPERTENSIVE DRUGS: A REVIEWHTML Full Text
ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF TERTIARY COMBINATIONS OF ANTIHYPERTENSIVE DRUGS: A REVIEW
Purva Patel and Hiral Dave *
Department of Pharmaceutical Quality Assurance, Parul Institute of Pharmacy, Parul University, P.O Limda, Vadodara, Gujarat, India.
ABSTRACT: The most important risk factor for cardiovascular disease is high blood pressure, which accounts for around one-third of those who have it. A majority of those who have hypertension are not on antihypertensive medication. It is not a disease, but it is an important risk factor for cardiovascular disease. Hypertension includes the intricate exchange of natural and pathophysiological factors that influence numerous frameworks, just as hereditary inclination. Investigation of patients with hypertension incorporates exact normalized blood pressure (BP) estimation, evaluating patients' anticipated danger of atherosclerotic cardiovascular disease, declaration of target organ harm, location of auxiliary reasons for hypertension, and presence of comorbidities, including cardiovascular disease kidney infection. As a part of many risk factor reduction activities, combination drug therapy is as a well-established option for cardiovascular disease risk reduction. Over the past couple of years, there has been much research done on antihypertensive drugs and there have been many patents that can be beneficial for research purposes. A key element of discovering new drugs, advancing new drugs and assembling pharmaceutical products is the development of analytical methods and their validation. Analytical methods should be used in the Good Manufacturing Practice and Good Laboratory Practice environments and must be developed using the protocol and acceptance criteria in the ICH Q2(R1) guidelines. The following literature surveys reveal that all methods were reported for all tertiary combinations. However, Ultraviolet spectrophotometry Reverse Phase High-Performance Liquid Chromatography, High-Performance Thin-Layer Liquid Chromatography, stability-indicating Reverse Phase High-Performance Liquid Chromatography methods.
Keywords: Analytical method, Hypertension, High-performance liquid chromatography, Liquid chromatography-mass chromatography, High-performance thin layer liquid chromatography, Patent search, Ultraviolet spectroscopy
INTRODUCTION: Anti-hypertensives drugs are used to treat hypertension (high blood pressure). People with hypertension are very commonly seen to suffer from this chronic condition.
Current hypertension treatment guidelines recommend a goal of <140/90 mmHg> for a population with uncomplicated hypertension, and goals are even <130/80mmHg> for patients with diabetes or renal disease.
According to the studies that have been conducted over the long term, the higher the blood pressure reduction, the lower the cardiovascular death risks. Major clinical studies have revealed that most patients require two or more drugs to reach their blood pressure goals.
Evidence suggests that lowering the blood pressure by 5mm Hg can decrease the risk of stroke by 34%, ischemic heart disease by 21% and reduce the likelihood of dementia, heart failure and mortality from cardiovascular disease 2.
Combination therapy should be used as the initial treatment of patients whose probability of achieving monotherapy's BP control is low. As many risk factors as possible can be reduced by using combination drug therapy to reduce cardiovascular disease risk.
Type of Hypertension: There are two types of hypertension. Primary hypertension (Essential). Secondary hypertension.
Primary Hypertension: Primary hypertension is the most common type, affecting between 90-95% of patients diagnosed with essential hypertension. Primary hypertension does not have to be identified clearly. The majority of cases are of essential hypertension i.e., the cause is not known.
Sympathetic and renin-angiotensin systems may or may not be overactive, but they contribute to blood vessels' tone 3. In this case, hypertension greater than 130 systolic and 80 diastolic has occurred without any diagnosis or treatment.
There can be multiple risk factors contributing to primary hypertension, including excessive salt consumption, abnormalities involving the renin-angiotensin-aldosterone system, and pathogenic disturbances of the CNS such as stress.
Secondary Hypertension: It has been discovered that secondary hypertension causes 5% of all hypertension cases. A medical condition (such as kidney or liver malfunction) or medication can result in high blood pressure.
An abnormality in the arteries supplying blood to the kidneys is the most common cause of hypertension. Additionally, some people suffer from thyroid diseases, hormonal abnormalities, tumors of the adrenal glands, and airway obstructions during sleep if they consume too much salt or alcohol.
Pathophysiology of Hypertension: Hypertension results from irregular physiological regulation of blood pressure resulting from multiple mechanisms. The blood pressure is a product of cardiac output and systemic vascular resistance.
The blood pressure is determined by the interaction of multiple genetic, environmental and demographic factors that influence to hemodynamic variables shown in Fig. 1, cardiac output, and total peripheral resistance. Cardiac output is affected by the blood volume, itself greatly dependent on body sodium homeostasis 5.
As the blood vessels contract, humoral factors that cause vasoconstriction (such as angiotensin II) and vasodilators (prostaglandins and nitric oxide) are activated. Resistance vessels also exhibit autoregulation, whereby increased blood flow induced vasoconstriction to fight against tissue hyperperfusion.
Other local factors such as pH and hypoxia and neural interactions (α- and β- adrenergic systems) may be important 4. The kidneys play a significant role in blood pressure regulation, as follows:
- In the renin-angiotensin system, the kidney influence both peripheral and sodium hemostasis. The juxtaglomerular cells of the kidney produce renin to change plasma angiotensinogen into angiotensin I, which is then converted by angiotensin-converting enzyme (ACE) to angiotensin II 4.
- Angiotensin II increases peripheral resistance and blood volume simultaneously, shown as in 2.
- The kidneys also produce a vasodepressant that counterbalances angiotensin's effects as a vasodepressant.
- In response to volume expansion, heart atria secrete natriuretic factors independent of the glomerular filtration rate, which inhibit sodium reabsorption by distal tubules and cause vasodilation 4.
- When the renal excretory function is impaired, n creased atrial pressure is a compensatory mechanism to restore fluid and electrolyte balance 4.
FIG. 1: GENETIC INFLUENCE +ENVIRONMENT FACTOR RELEVANT TO HYPERTENSION
FIG. 2: RENIN ANGIOTENSIN ALDOSTERONE SYSTEM
Proposed Disease Treatment: Controlling and managing high blood pressure can be achieved by changing your lifestyle. In England and Wales, over seven million adults appear on the initial care hypertension registers, which is around 14% of the adult population 5. By lowering BP to an acceptable level with minimal patient inconvenience, antihypertensive therapy can help prevent morbidity and mortality associated with persistently raised BP. Control technology has an important role to play in this scenario. Currently, 60% of those on hypertensive enrol are controlled 6 and only 50% of those starting on a new antihypertensive remaining taking it after 6 months 7.
Lifestyle Change: Different forms of non-pharmacological treatment to lower blood pressure and prevent hypertension. The most effective interventions are weight loss 8, 9, reduced Na+ intake 9, 10, 11, increased potassium intake 12, 13, increased physical activity 14, reduced consumption of alcohol 15 and diets like the Dietary Approaches to Stop Hypertension (DASH) diet that includes elements that have favourable effects on blood pressure. The DASH diet is especially successful when combined with other effective BP lowering interventions such as a reduced dietary sodium intake 16. A lifestyle change is the most effective method of implementing these interventions.
Pharmacological Interventions: Low-dose pharmacological therapy has also been shown to be impressive in lowering BP and preventing hypertension in three randomized controlled trials conducted in adults with high normal BP 17, 18. The Brazilian multicenter PREVER-Prevention Trial compared treatment with the low-dose long-acting thiazide-like diuretic chlorthalidone in combination with the potassium-sparing agent amiloride with treatment with placebo 19. Amiloride and chlorthalidone both lower blood pressure and hypertension, including a reduction in left ventricular mass when combined with low dose chlorthalidone.
Management of Hypertension:
Initiation of Antihypertensive Drug Therapy: Importantly, though the diagnosis of hypertension has been confirmed at the 130/80 mm Hg threshold, most patients with stage 1 hypertension (∼69%) do not qualify for immediate drug therapy 20. In first-line therapy for pharmacological treatment of patients with masked hypertension, prescription of drug therapy is four drug classes- thiazide diuretics, calcium antagonists, ACE inhibitors, and angiotensin receptor blockers unless there is comorbidity consideration favoring the use of different class of the drugs.
Combination Therapy: Guidelines from WHO, ISH, and BHS encourage single-drug therapy; however, a second (and third, or even fourth) drug may be prescribed when the primary therapy fails. The hypertension study found that 70% of patients who achieved target blood pressure took two or three drugs. In the management of hypertension, few studies have been conducted on how the different combinations perform. Table 1 shows a list of recommended and not recommended 21.
A combination of antihypertensive agents is a fixed dose or free combination, including a diuretic. These combinations have been shown to produce greater blood pressure reductions than those seen with monotherapies 24. Combinations of a calcium antagonist with a renin-angiotensin system inhibitor (RASI), whether an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) 25, 26, have also been shown to be effective and safe in the management of the hypertensive patient 25, 26. Patients with left ventricular hypertrophy, who are taking ACE inhibitors/ARBs, benefit greatly from this combination.
TABLE: 1 RECOMMENDED AND NOT RECOMMENDED COMBINATIONS
|Recommended combinations||Not recommended
|Diuretics with angiotensin-renin axis inhibitors or calcium antagonist||Two agents that inhibit the renin–angiotensin axis (derived from a warning published by the Food and Drug Administration, dated 20 April 2012 22|
|Inhibitors of the renin-angiotensin axis with diuretics or with calcium antagonist||Diuretics with beta blockers (greater risk of development of type 2 diabetes, as found in the ASCOT trial 23|
|Beta adrenergic blockers with dihydropyridine calcium antagonist||Beta-adrenergic blockers with non-dihydropyridine calcium antagonists (greater risk for bradycardia and/or atrio-ventricular block 22|
Patent Search for Antihypertensive Drugs: Over the past couple of years, there has been much research done on antihypertensive drugs. There have been many patents that can be beneficial for research purposes. Table 2 shows a list of the patent search for antihypertensive drugs.
TABLE 2: PATENT SEARCH
|S. no.||Patent application number||Patent title||Summary|
|1||EP2255791A1||Extended-release pharmaceutical composition compressing metoprolol succinate 27||is related to the Extended-release pharmaceutical composition compressing metoprolol succinate 27|
|2||CN111517967A||Synthesis method of metoprolol succinate isomer impurities 28||The invention belongs to the technical field of medicinal chemistry and particularly relates to a synthesis method of metoprolol succinate isomer impurities 28|
|3||US2017340583A1||Capsule dosage form of metoprolol succinate 29||This disclosure provides an extended-release capsule dosage form of metoprolol succinate in the form of coated discrete units, wherein said capsule dosage form is bioequivalent to the marketed Toprol-XL®tablet 29|
|4||WO2007141593A2||Improved synthesis and preparation of metoprolol succinate 30||The invention relates to an improved process for preparing metoprolol and its salts 30|
|5||CN102552196A||Spray drying method for preparing metoprolol succinate sustained-release capsule 31||The invention provides a spray-drying method for preparing metoprolol succinate sustained-release capsule 31|
|6||WO2018158777A1||Improved process for the preparation for chlorthalidone 32||The present invention relates to methods for preparing chlorthalidone. In particular, the disclosed processes are feasible on an industrial scale and provide substantially pure chlorthalidone 32|
|7||WO2015153379A1||Fixed-dose combination of angiotensin converting enzyme (ACE) inhibitor and the diuretic chlorthalidone 33||The invention describes fixed dosage formulations of an angiotensin-converting enzyme (ACE) inhibitor, preferably Lisinopril and the diuretic, preferably Chlorthalidone in the same pharmaceutically acceptable carrier, for example a tablet, capsule 33|
|8||US2010204252A1||Method of treating hypertension with at least one AngiotensinII receptor blocker and chlorthalidone 34||The present invention relates to a method of treating hypertension in a subject or patient needing treatment thereof by administering to said subject or patient at least one angiotensin II receptor blocker in combination with chlorthalidone 34|
|9||US2017157094A1||Pharmaceutical formulation comprising losartan potassium and chlorthalidone 35||The invention is a pharmaceutical tablet formulation comprising between about 12.5 mg and 100mg losartan potassium, between about 6.25mg 50mg chlorthalidone 35|
|10||WO2020207355A1||Pharmaceutical composition containing amlodipine, chlorthalidone, amiloride 36||is related to the Provided is a pharmaceutical composition for treating refractory hypertension. The pharmaceutical composition consists of amlodipine, chlorthalidone, and amiloride 36|
|11||CN107966519A||High-performance liquid chromatography analysis method and detection method for impurities in telmisartan medicine 37||The invention relates to the detection of Telmisartan, and particularly discloses a high-performance liquid chromatography analysis method and a detection method for impurities in a Telmisartan medicine 37|
|12||CN110836943A||Analysis method for impurity detection of telmisartan tablet and telmisartan capsule 38||The invention provides an analysis method for detecting impurities in telmisartan tablets and telmisartan capsules, and belongs to the field of drug detection 38|
|13||US2006111417A1||Amorphous telmisartan 39||Amorphous telmisartan and combination of amorphous telmisartan with one or more pharmaceutical carrier 39|
|14||WO2010063997A1||Telmisartan formulation 40||A telmisartan tablet is formulated with 60 % or more water soluble diluent, avoiding the need for surfactant or a basic amino acid solubilizing agent 40|
|15||CN101049305A||Telmisartan pills and preparation method 41||A dripping pill of telmisartan for treating hypertension is prepared from the telmisartan and the matrix of dripping pill. Its preparation process is also disclosed 41|
|16||CN108888593A||Atenolol injection and preparation method thereof 42||The atenolol injection is prepared from atenolol and sodium chloride, each 100ml of injection contains 30-70mg of atenolol and 0.45-1.8g of sodium chloride 42|
|17||CN106176582A||Atenolol emulsifiable paste for testing infant hemangioma and method for preparing atenolol emulsifiable paste 43||The invention belongs to the field of technologies for preparing medicines, and particularly relates to atenolol emulsifiable paste for treating infant hemangioma and a method for preparing the atenolol emulsifiable paste 43|
|18||CN109771497A||Antihypertensive capsule and preparation method 44||The invention belongs to the technical field of traditional Chinese medicine and discloses an antihypertensive capsule and a preparation method 44|
|19||CN109771497A||Cocrystal of telmisartan and hydrochlorothiazide 45||The present disclosure relates to a cocrystal of telmisartan and hydrochlorothiazide, a preparation method and use thereof 45|
|20||CN112641745A||Telmisartan hydrochlorothiazide tablet and preparation method thereof 46||The invention discloses a telmisartan hydrochlorothiazide tablet and a preparation method thereof 46|
|21||CN112516105A||Losartan potassium oral preparation and preparation method thereof 47||The invention relates a losartan potassium oral preparation 47|
|22||CN112274490A||Preparation method of amlodipine losartan potassium compound composition 48||The invention discloses a preparation method of amlodipine of and losartan potassium compound composition 48|
|23||CN112438986A||Application of losartan potassium and dacarbazine combined medicine for treating intestinal cancer 49||The invention belongs to the field of medicines, and particularly relates to an application of losartan potassium and dacarbazine combined medicine to preparation of a medicine for treating intestinal cancer 49|
|24||CN111956624A||Olmesartan medoxomil tablet and preparation method thereof 50||The invention discloses an Olmesartan medoxomil tablet and a preparation thereof 50|
|25||CN111004223A||preparation and separation method of Olmesartan medoxomil dimer impurity 51||The invention provides a preparation and separation method of an Olmesartan medoxomil dimer impurity 51|
|26||CN112315926A||Valsartan oral solid preparation 52||The invention relates to the technical field of biological medicines, in particular to a valsartan oral solid preparation 52|
|27||WO2021022516A1||Valsartan refinement method 53||Disclosed is a valsartan refinement method comprising firstly, reacting valsartan in water with an alkali or a salt of a strong and a weak acid to generate a valsartan salt 53|
Analytical Method Validation: The development and validation of analytical methods play a crucial role in developing, advancing, and assembling pharmaceutical products. An analysis of drug substances and drug products includes determining their purity and toxicity.
A method of developing analytical methods primarily employed in multicomponent analyses minimizes the time-consuming task of separating interferants and, therefore, reduces time and therefore costs, associated with the analysis of increasingly more analytes. The number of medications introduced to the market has increased in recent years. The steps of method development and validation depend upon type of method being developed; the following steps are common to most types of projects.
- Method development plan definition.
- Background information gathering.
- Laboratory method development.
- Generation to test procedure.
- Method validation protocol definition.
- Laboratory method validation.
- Validated test method generation.
- Validation report.
ICH Q2(R1) guidelines also mention that analyses must adhere to GMP and GLP practices; protocols and acceptance criteria must be followed when developing analytical methods 54.
Development and validation of analytical methods play a critical role in pharmaceutical manufacturing and develop-pmentthe following literature surveys reveal there is all methods were reported for all tertiary combinations. However, UV spectro-photometry, RP- HPLC, HPTLC, and stability indicate RP-HPLC methods. The reported methods are shown in Table 3.
TABLE 3: REPORTED METHODS FOR ASSESSMENT OF TERTIARY COMBINATIONS
|S. no.||Title / Method||Description|
|1||Application of an LC-MS/MS method for the analysis of amlodipine, valsartan and hydrochlorothiazide in polypill for bioequivalence study 55||Extract:100µL human plasma by solid extraction on oasis HLB cartridges, Column: RP18e, Concentration range: VAL:5.00-10,000ng/ml, HCTZ :20-200ng/ml, AML:0.02–20.0 ng/mL|
|2||Development and validation of analytical method for simultaneous estimation of cilnidipine, chlorthalidone and telmisartan in tablet dosage form 56
(RP HPLC method)
|Matrix: Tablet, Mobile phase: 0.025Mpotassium dihydrogen phosphate: ACN (75:25), Flow rate:1.0 mL/min, Detector wavelength :233 nm
|3||Comparison of Partial Least Squares Regression and H-Point Standard Addition Method for Simultaneous Spectrophotometric Determination of Losartan Potassium, Hydrochlorothiazide and Amlodipine Besylate in Tablets 57||Matrix: Tablet, MATLAB software version 7.5 (The MathWorks) and PLS – Toolbox version 5.0 (Eigen Vector Technologies).
Solvent:0.1M NaOH: water (20:80), Wavelength: LOS:228.41nm, HCTZ:216.32nm, AML:216.32nm
|4||Development and Validation of HPLC Method for Simultaneous Determination of Amlodipine, Valsartan, Hydrochlorothiazide in Dosage Form and Spiked Human Plasma 58||Matrix: tablet, spiked human plasma, Column: C18, Mobile phase: acetonitrile: phosphate buffer (0.05 M) (40:60), flow rate: 0.8 mL/min, wavelength detection: 227 nm.|
|5||Development and Validation of HPTLC Method for Simultaneous
Estimation of Amlodipine Besylate, Hydrochlorothiazide and Telmisartan in Their Combined Tablet Dosage Form 59
|Matrix: Tablet, Stationary phase: silica gel, Mobile phase: chloroform: butan-1-ol: ammonia (6: 4: 0.1, v/v/v), Detector wavelength :254nm|
|6||H-point standard addition method for simultaneous spectrophotometric determination of irbesartan, hydrochlorothiazide and telmisartan in tablets 60||Matrix: Tablet, MATLAB software version 7.5 (The Math Works) and PLS – Toolbox version 5.0 (Eigen Vector Technologies), Solvent:0.1M NaOH: water (20:80 v/v), Wavelength: IRB:228.41nm
HCZ:216.32nm, TEL: 295.12nm
|7||Simultaneous estimation of hydrochlorothiazide, amlodipine,
and losartan in tablet dosage form by RP-HPLC 61
|Matrix: tablet, Column: C18, Mobile phase: acetonitrile: water 0.4% of potassium dihydrogen phosphate (45:35:20), flow rate: 1 mL/min
wavelength detection:230 nm
|8||Simultaneous spectrophotometric determination of losartan potassium, amlodipine besylate and hydrochlorothiazide in pharmaceuticals by chemometric methods 62||Matrix: Tablet, MATLAB software version 7 (The Mathworks) and PLS – Toolbox version 5.0 (Eigen Vector Technologies). Solvent: Methanol , Wavelength:230.5–350.4 nm|
|9||Development and Validation of Stability-indicating Method for the Estimation of Cilnidipine, Olmesartan Medoxomil and Chlorthalidone by Reverse Phase High Performance Liquid Chromatography 63||Matrix: Tablet, Column: c18, Mobile phase: 0.01 N Potassium dihydrogen phosphate buffer: ACN (60:40), Flow rate: 0.9 mL/min.
Detector wavelength: 260 nm
|10||Rapid Simultaneous Determination of Telmisartan, Amlodipine Besylate and Hydrochlorothiazide in a Combined Poly Pill Dosage Form by Stability-Indicating Ultra Performance Liquid Chromatography 64||Column: c18, Mobile phase:sodium perchlorate buffer(0.053M): ACN (90:10 v/v), Flow rate:0.6 mL/min, Column temperature: 55°C
Wavelength: HCTZ:271 nm, AMLB:237 nm, TEL:271 nm
|11||Related Impurities High-performance Liquid Chromatography Method Development and Validation for drug combinations: Olmesartan Medoxomil, Chlorthalidone and Cilnidipine 65||Matrix: Tablet, Column: c18, Mobile phase:ammonium acetate: ACN (55:45 v/v) , Flow rate:1.0 mL/min, Detector Wavelength: 260nm|
|12||RP-HPLC method development & validation for simultaneous estimation of chlorthalidone, metoprolol succinate and telmisartan in tablets 66||Matrix: Tablet, Column: c18, Mobile phase:0.5M potassium dihydrogen ortho phosphate: methanol (50:50v/v), Flow rate:1.0 mL/min, Detector Wavelength: 215nm|
|13||RP-HPLC Method Development and Validation for Simultaneous Estimation of Amlodipine besylate, Valsartan and Hydrochlorothiazide in Tablet Dosage Form 67||Matrix: Tablet, Column: c18, Mobile phase:ACN: Phosphate buffer (55:45 v/v), Flow rate:1.0 mL/min, Detector Wavelength: 237nm|
|14||Separation of Marketed Formulation containing Hydrochlorothiazide Amlodipine and Losartan through RPHPLC Method 68||Matrix: Tablet, Column: c18, Mobile phase:Acetonitrile, methanol (65:35), Flow rate:1.5 ml/min., Detector Wavelength: 230nm|
|15||Simultaneous Analysis of Losartan Potassium, Amlodipine Besylate, and Hydrochlorothiazide in Bulk and in Tablets by High-Performance Thin Layer Chromatography with UV-Absorption Densitometry 69||Matrix: bulk and Tablet, Stationary phase: silica gel, Mobile phase: chloroform: methanol: acetone: formic acid 7.5:1.3:0.5:0.03 (v/v/v/v), Densitometric scanning: 254nm|
|16||Simultaneous determination of valsartan, amlodipine besylate and
hydrochlorothiazide using capillary zone electrophoresis (CZE) 70
|Matrix: Tablet, Separation: fused silica capillary by applying a potential of 15 Kv, Temperature: capillary cartridge, was kept at 25 ◦C, UV detection: 230 nm|
|17||Stability-Indicating Method for Simultaneous Estimation of Olmesartan Medoxomil, Amlodipine Besylate and Hydrochlorothiazide by RP-HPLC in Tablet Dosage Form 71||Matrix: Tablet, Column: c18, Mobile phase:triethylamine: ACN (60:40 v/v), Flow rate:1.4mL/min, Detector Wavelength: 236nm|
|18||Simultaneous estimation of telmisartan, chlorthalidone and cilnidipine by absorbance correction method using UV spectrophotometry 72||Matrix: Tablet, Solvent: Methanol, Wavelength: CHL:225nm, TEL:325nm, CIL:350nm|
|19||UPLCMS Method Development and
Validation of Amlodipine,
Hydrochlorothiazide and Losartan in
Combined Tablet Dosage Form 73
|Matrix: Tablet, Column: c18, Mobile phase: ACN: ammonium acetate (98:2v/v), Flow rate :0.4 ML/min|
|20||Validated RP-HPLC Method for Simultaneous Estimation of Atenolol, Hydrochlorothiazide and Losartan Potassium in Bulk and Pharmaceutical Dosage Form 74||Matrix: Tablet, Column: c18, Mobile phase: ACN: Potassium, dihydrogen ortho phosphate (40:60V/V), Flow rate:1.5 mL/min, Wavelength detection :225nm|
|21||Development and validation of RP HPLC method for simultaneous estimation of metoprolol, telmisartan and cilnidipine in tablet 75||Matrix: Tablet, Column: c18, Mobile phase: ACN: methanol: phosphate buffer (45:30:25), Flow rate: 1.0 ml/min, Wavelength detection :229nm|
|22||Determination of losartan, telmisartan, and valsartan by direct injection of human urine into a column-switching liquid chromatographic system with fluorescence detection 76||Matrix: injection, Column: Chromolith RP-18e monolithic column, Mobile phase: phosphate buffer: ACN: methanol (65:20:15, v/v/v),Flow rate: 3.0 mL/min
|23||Spectrophotometric method for simultaneous estimation of atenolol in combination with losartan potassium and hydrochlorothiazide in bulk and tablet formulation 77||Matrix: Bulk and Tablet, Solvent: methanol, Wavelength: ATE:224.20nm, LOP: 251.60nm, HCTZ: 271.60nm
|24||Novel RP-HPLC method for simultaneous determination of Olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide in tablet dosage form 78||Matrix: Tablet, Column:c18, Mobile phase: phosphate buffer: ACN (50:50 v/v), Flow rate: 3.0 mL/min, Detector wavelength:262nm
CONCLUSIONS: All tertiary combination drugs are shown to be more effective in this article. A literature review is presented to provide information on different methods for determining all combinations of tertiary drugs. Several patents have been published on antihypertensive drugs in the last two or three years that are helpful to researchers.
The different analytical methods are reported for the combinations like UV Spectroscopy, HPLC, LC-MS, HPTLC, stability-indicating, and RP-HPLC. Additionally, this article presents the pharmacological action and solubility of all tertiary combinations. This review will help develop the analytical method for these new combinations and gives the knowledge about the characteristics of all tertiary combination’s drugs.
ACKNOWLEDGEMENT: We wish to acknowledge the Department of Pharmaceutical Quality Assurance at Parul Institute of Pharmacy, Parul University, for his help and support in the compilation of the article.
CONFLICTS OF INTEREST: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of this article.
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How to cite this article:
Patel P and Dave H: Analytical method development and validation of tertiary combinations of antihypertensive drugs: a review. Int J Pharm Sci & Res 2022; 13(9): 3447-57. doi: 10.13040/IJPSR.0975-8232.13(9).3447-57.
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Purva Patel and Hiral Dave *
Department of Pharmaceutical Quality Assurance, Parul Institute of Pharmacy, Parul University, P.O Limda, Vadodara, Gujarat, India.
11 January 2022
24 February 2022
01 September 2022
01 September 2022