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THE COMPLITE REVIEW ON ANALYTICAL AND FORMULATION TECHNIQUES OF GLIPIZIDE

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THE COMPLITE REVIEW ON ANALYTICAL AND FORMULATION TECHNIQUES OF GLIPIZIDE

Rashmi Balkate 1, Shrikrishna Baokar 2, Hrushikesh Joshi *1 and Rajendra Patil 2

Department of Pharmaceutics 1, Department of Pharmaceutical Analysis 2, Shivnagar Vidya Prasarak Mandal’s College of Pharmacy, Malegaon (Bk), Baramati, Pune - 413115, Maharashtra, India.

ABSTRACT: Glipizide is second generation Short acting sulfonylurea prescribed for treatment of type II diabetes Mellitus. It is with short biological half-life of 3.4 ± 0.7 hrs and metabolized in the liver and excreted in the urine largely as inactive metabolites. The clinical and pharmaceutical analysis of drug requires analytical procedures along with pharmacokinetic and pharmacodynamic data with stability study for any analysis of drug. In the present review we have compiled different published analytical methods for determination of glipizide in pharmaceutical methods. The table no 1 indicate Analytical method development and validation of single Glipizide drug by HPLC method; while table no 2 indicates Analytical method development and validation of glipizide with combination of other drugs by HPLC method. In the literature review table no 3 and 4 indicates Analytical method development and validation of glipizide as well as other drugs in combined forms by UV spectrophotometer. This literature review also involved tabulated information about various formulations available of glipizide along with their method of formulation and polymers used in the formulations.

Keywords:

Glipizide, Pharmacokinetic parameters, Pharmacodynamic parameters, UV Spectrophotometer, HPLC method

INTRODUCTION: Chemically, Glipizide (GLP) is a substituted aryl-sulphonylurea. Its empirical formula is C21H27N5O4S, molecular weight is 445.55 gm and IUPAC name is 1-cyclohexyl-3-[[p-[2-(5 methylpyrazinecarboxamido) ethyl] phenyl] sulfonylurea] 1. GLP is a medium to long acting anti‐diabetic drug and commonly used to lower blood glucose level in patients with type two diabetes mellitus 2.

As GLP is second generation sulfonylurea, which means it undergoes entero-hepatic circulation and act by stimulating the release of insulin from the pancreases and hence reducing blood glucose level in human beings 3. GLP bind to KATP channels on the cell membrane of pancreatic β cells of the islets of Langerhans. This leads to increased fusion of insulin granulae with the cell membrane, and therefore increased secretion of insulin 4.

It is a weak acid (pKa = 5.9) practically insoluble in acid solution but as per biopharmaceutical Classification System (BCS) it is highly permeable 5. GLP is poor water soluble drug and is practically water-insoluble but, its absolute bioavailability is close to 1 and its dissolution is considered to be rate limiting step (i.e., an effective factor) in its absorption from gastrointestinal tract 6, 7. GLP face problem of low bioavailability. Various approaches have been suggested for designing dissolution tests for poorly water-soluble drugs. These include (a) use of large volumes of dissolution medium, (b) removal of dissolved drug, (c) mixed organic aqueous solvents, (d) two phase dissolution media with an upper organic layer, (e) the inclusion of surfactants, (f) pH changes 8.

It is reported to have short biological half-life (3.4±0.7 hr) make it a suitable candidate to be formulated for the sustained delivery system 9. GLP requires to be administered in 2 to 3 doses of 2.5 to10 mg per day 10, 11. It exerts side effects such as severe overdose symptoms include low blood sugar, hypoglycemia and gastric trouble, Sweating Shakiness, Extreme hunger, Dizziness, Cold sweats, Blurry vision etc 12.

FIG. 1: STRUCTURE OF GLIPIZIDE

This Table 1 of literature review shows a rapid, simple and sensitive RP-HPLC method for development and validation of single Glipizide drug along with the information like stationary phase and mobile phase used along with their retention time and flow rate with UV detection.

TABLE 1: ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF GLIPIZIDE BY HPLC METHOD              

S. no. Research

work

 Stationary Phase Mobile

Phase

 Detection Flow Rate (ml/min) Retention Time  (min) Ref. no.
1 Development and Validation of RP-HPLC Method for Estimation of Glipizide in Bulk Drug and Pharmaceutical Formulation C18 (ODS

150 mm × 4.6 mm ×3 μm)

 Acetonitrile: Water

(60:40)

 UV  at 276 nm 1 2.4 13
2 Development and validation of RP-HPLC-UV method for the determination of Glipizide in human plasma C18

(ZORBAX ODS,150 mm × 4.6 mm × 5μm )

 0.01 M Phosphate buffer

(pH 4.25 adjusted by glacial acetic acid): Acetonitrile (65:35)

 UV  at 275 nm 1.5 10.5 14
3 Development And Validation Of  HPLC  Method for the Estimation of Glipizide In Pharmaceutical Dosage Forms C18(Symmetry l50 mm x 4.6 mm × 3.5 μm) Phosphate buffer

(pH 3.5): Acetonitrile (40:60)

 UV  at 233 nm 1.0 2.82 15
4 Estimation Of Glipizide In Commercial Drugs By RP-HPLC C18 (Kromosil 250 mm × 46mm × 5 μm) Methanol: Acetonitrile: Water

(40:40:20)

 UV  at 256 nm 1 3.62 12
5 Glipizide Pharmacokinetics in Healthy and Diabetic Volunteers C 18

ODS

 Acetonitrile: 0.01M KH2PO4 buffer(pH 3.5)

(35 : 65)

 UV  at 275 nm 1.5 5.24 ± 0.31 16
6 High Performance Liquid Chromatographic Analysis of Glipizide: Application to In Vitro and In Vivo Studies C18

(Waters Spherisorb S5 ODS2 (4.6 mm× 250 mm × 5μm)

 Acetonitrile: 0.05M KH2PO4

(pH 3.5 with o-Phosphoric acid (50:50)

 UV  at 275  nm 1.5 7.87 17
7 Development and Validation of LC Method for the Estimation of Glipizide in Pharmaceutical Dosage Form and Serum C18(Inertsil ODS, 45 mm ×15mm × 5 μm) Methanol: Water: 0.01M,  KH2PO4)

(70:25:5)

 UV  at 270 nm 1.5 18
8 Reverse phase High Performance Liquid chromatography method for analysis of Glipizide in Pharmaceutical dosage forms C18 (InertsilODS250mm × 4.6mm × 1μm) Methanol: 0.05 M KH2PO4

(pH 7, adjusted by 1% Triethylamine

(85:15)

 UV  at 225 nm 1 3.21 19
9 Development And Validation of LC Method for the Estimation of Glipizide In Pharmaceutical Dosage Form And Serum C-18 (Inertsil ODS 250 mm x4.6mm × 5μm) Methanol: Water: 0.01M KH2PO4 (70:25:5) UV  at 270 nm 1.5 3.211 4
10 Development and Validation of RP-HPLC Method for Analysis of Glipizide in Guinea Pig Plasma and its Application to Pharmacokinetic Study PC-Micra NPS RP18

(33 mm × 4.6 mm × 1.5 μm)

 Phosphate Buffer

(pH 3.5): Acetonitril (ACN): THF

(80:15:5)

 UV  at 275 nm 0.4 2.01 20
11 Glipizide matrix transdermal systems for diabetes mellitus: Preparation, in vitro and preclinical studies C 18 20 M KH2PO4 in water  (pH 3.5 adjusted by  Phosphoric acid): Acetonitrile  (65:35 ) UV  at 275 nm 1 6.67 21
12 Development and Evaluation of Swellable Elementary Osmotic Pump Tablet of Glipizide C18

(ODS250 mm × 4.8 mm ×5μm)

 Acetonitrile (ACN): 0.01M Phosphate buffer (pH 3.5) (35:65) UV  at 274 nm 1 8.1 7
13 Development and validation of RP-HPLC method for quantification of glipizide in biological macromolecules C 18 (Hypersil ODS) 10 mM Phosphate buffer

(pH 3.5): Methanol (25:75).

 UV  at 230 nm 1 7.32 22

This Table 2 of literature survey reveals that, the spectrophotometric HPLC methods are available for individual Glipizide, with other combined drug like Metformin, Repaglinide and other similar drugs in pharmaceutical preparations and biological formulations along with information like stationary phase and mobile phase used along with their retention time and flow rate with UV detection.

TABLE 2: ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF GLIPIZIDE AND OTHER DRUGS BY HPLC METHOD

S. no. Research

work

 Stationary Phase Mobile Phase Detection Flow Rate (ml/min) Retention Time  (min) Ref. no.
1 Novel RP-HPLC Method For Metformin HCl, Glipizide And Repaglinide Pharmaceutical Drug Products C18 (Zodiac  150mm x 4.6mm × 3.5μm) Phosphate buffer(pH 3): Acetonitrile (45:45) UV at

210 nm

 1 3.71 23
2 Development and Validation of RP-HPLC Method for Simultaneous Determination of Glipizide, Rosiglitazone, Pioglitazone, Glibenclamide and Glimepiride in Pharmaceutical Dosage Forms and Human Plasma C18

(ODS150mm × 4.6 mm ×5 μm)

 Phosphate buffer

(pH 3.5): Acetonitrile: Methanol (55:15:30)

 UV at

248 nm

 1 4.51 24
3 Development of a RP-HPLC Method for Simultaneous Determination of Some Antidiabetic Sulfonylurea Drugs in Bulk and Pharmaceutical Dosage Forms C18

(ODS

150 mm × 4.6 mm × 5 μm)

 Methanol:  Acetonitrile: Phosphate buffer (pH 3.5) (60:10:30) UV at

230 nm

 1.5 8.0 25
4 Formulation Development and Assessment of Controlled Release Bilayered Osmotic Tablet Carrying Sulfonylurea Class Anti Diabetic Agent & Imperative Factors Imparting Significant Impact on Drug Release C18

(ODS

15cm × 3.9mm × 4μm)

 Phosphate buffer (pH 7.5): Acetonitrile (60:40) UV at 225nm 1 6.21 26
5 Formulation and evaluation of bilayered gastro retentive floating tablets containing metformin HCl and glipizide C18 (Symmetry 150 mm × 4.6 mm x 5μm) Methanol: Phosphate buffer

( pH 1.2)

(50:50)

 UV at

225 nm

 0.8 10.0 27
6 Glipizide and Metformin Hydrochloride Tablets C 18

(ODS 25 cm ×4.6 mm ×5 μm)

 Methanol : phosphate buffer (pH 6.0) (1:1) UV at

260 nm

 1 3.0 28
7 Development and Validation of Reverse phase High Performance Liquid chromatography method for Simultaneous  Estimation of Glipizide and Metformine in Tablet Dosage Forms C 18

(ODS

250 mm  x 4.5 mm × 5μm)

 0.2 M Phosphate buffer

( pH 5.8): Acetonitrile

(60: 40)

 UV at

218 nm

 1 7.9 29
8 Simultaneous Determination of Glipizide and Glimepride by RP-HPLC In Dosage Formulations and In Human Serum C18 (Nucleosil 10 cm ×

25 mm ×

0.46 μm)

 Methanol: Water

(80:20 )

 UV at

230 nm

 1 3.13 30
9 Simultaneous Estimation of Metformin and Glipizide By RP-HPLC and its Validation C 18

(Intersil

250 mm x 4.6 mm ×

5 μm)

 Phosphate buffer

( pH 8.0): ACN

(50:50)

 UV at

257 nm

 2 4.21 31
10 Single and high resolution RP-HPLC method for the determination of six anti diabetic drug products C18

(ODS 150mm× 4.6mm × 3μm)

 Phosphate buffer (pH

3) by H3PO4 acid: Acetonitrile (1:1)

 UV at

229 nm

 0.6 11.43 32
11 Stress degradation study of two oral antidiabetics, gliclazide and glipizide and chemical analysis by LC and LC/MS methods C18

(Poroshell 120SB

100 mm × 3.0 mm ×

2.7 μm)

 Phosphate buffer

( pH  4.3): Acetonitrile (60:40)

 UV  at 230 nm 1 3.7 33
12 Separation and Quantification of Eight Antidiabetic Drugs on A High-Performance Liquid Chromatography: Its Application to Human Plasma Assay C18

(100 mm × 4.6 mm ×

5 μm)

 0.05 % Formic acid: Methanol

(42 : 58)

 UV  at 234 nm 0.5 7.46 34
13 Development of stability indicating assay method for the simultaneous estimation of metformin hydrochloride and glipizide by RP-HPLC method C18

(ODS

250 mm × 4.6 mm×

5 μm)

 Acetonitrile:  Water (70:30) UV  at 222 nm 1.0 4.44 35
14 Validated Stability-Indicating HPLC-UV Method for Simultaneous Determination of Glipizide and Four Impurities C18

(250 mm × 4.5 mm ×

5 μm)

 Phosphate buffer (pH 3): Methanol

(60 : 40)

 UV  at 230 nm 0.5 8.0 36
15 Simultaneous Chromatographic Determination of a Critical Combination of Itraconazole, Clonazepam, and Glipizide C-18  (Hypersil BDS,150 mm x4.6 mm ×5 μm) Methanol: Water

(75:25 )

 UV  at 254 nm 1 2.50 37
16 Simultaneous Method Development and Validation for the Estimation of Metformin HCl and Glipizide in Bulk and Tablet dosage form by RP-HPLC C18

(Inertsil ODS

250 mm × 4.6 mm× 5μm)

 Phosphate buffer

(pH  3.5): Methanol (30:70)

 UV  at 240 nm 1.0 5.76 38
17 RP-HPLC Method for the Quantification and In-vitro Studies of Low Dose Oral Hypoglycemic Tablets C18

(Knauer  250 mm× 4.6 mm × 5μm)

 Phosphate buffer

(pH  2.8): Acetonitrile

(40:60)

 UV  at 230 nm 1.0 3.8 39

This Table 3 of literature survey reveals that a simple, accurate, validated and reproducible UV-Spectrophotometric method has been developed for the simultaneous estimation of Glipizide in different pharmaceutical formulations.

TABLE 3: ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF GLIPIZIDE BY UV METHOD

S. no. Experimental Work λMax Reference
1 Spectrophotometric determination of glipizide in bulk and tablet dosage form by absorption maxima, first order derivative spectroscopy and area under the curve 255 to

295 nm

 40
2 A validated new stability indicating densitometric method for quantitative analysis of glipizide in tablets 230 nm 41
3 Ultraviolet spectrophotometric method for determination of glipizide in bulk and tablet dosage formulation 227 nm 42

This Table 4 of literature survey reveals that a simple, accurate, validated and reproducible UV-Spectrophotometric method has been developed for the simultaneous estimation of glipizide and other drugs in combinations.

TABLE 4: ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF GLIPIZIDE AND OTHER DRUGS BY UV METHOD

S. no. Experimental Work λMax Reference
1 Simultaneous UV-Spectrophotometric Estimation of Glipizide and Metformin in Bulk and Its Dosage Form 276 nm 43
2 Simultaneous Estimation Glipizide and Metformin In Bulk and Tablet Dosage Form By Uv-Spectrophotometry 224 nm 44
3 development and validation of UV-visible spectrophotometric method for simultaneous determination of pioglitazone hydrochloride metformin hydrochloride and glipizide in its bulk and pharmaceutical dosage form (Tablet) 226.4 nm 45
4 Simultaneous spectrophotometric estimation of metformin hydrochloride and glipizide in tablet dosage forms 275 nm 46

TABLE 5: VARIOUS FORMULATIONS OF GLIPIZIDE DRUG AVAILABLE

S. no. Formulation Type Polymers Method Used Reference
1 Buccal Tablets Methocel K4M, Methocel K15M) and Carbopol 974, Magnesium stearate Direct Compression 47
2 Controlled Release Drug Delivery System Spray dried Lactose, PEO (4,000,000) Microcrystalline cellulose, Magnesium stearate, HPMC K100M,HPMC K 4M, HPMC K15M Direct Compression 48
3 Fast dissolving tablets MCC, DCP, Crospovidone, Croscarmellose PVP K-30, Pregelatinized Starch, Magnesium stearate, Starch, Aerosil. Direct Compression 49
4 Floating microspheres Poloxamer 188,  PVP K30, β-cyclodextrin, Gelucire, PEO, HPMC, Magnesium stearate, crospovidone, and  lactose Emulsion solvent evaporation 50
5 Floating Microspheres Ethylcellulose, HPMC K4M, HPMC K15M, Ethanol, Dichloromethane and Tween80 Emulsion solvent evaporation 51
6 Floating-Bioadhesive Tablets Chitosan, Hydroxypropylmethyl- cellulose, Carbopol P 934, Polymethacrylic acid, Citric acid and Sodium bicarbonate Direct compression 52
7 Gastroretentive Floating Tablets HPMC K100M, Sodium Alginate, Carbopol 940, Poly Vinyl Pyrrolidone  K 30, Sodium Bicarbonate, Citric Acid, Magnesium stearate, Starch, Aerosil. Direct Compression 53
8 Microcrystalliation PVA, Tween 80,

PEG 200

 Emulsion solvent diffusion 54
9 Microemulsion Glipizide, Capmul , MCM (6.5%), Cremophor, EL (25%), Transcutol P (7.5%), Distilled water, water titration 55
10 Mouth dissolving Tablet Sodium starch glycolate, Crospovidone, Pregelatinized starch Direct Compression 56
11 Mucoadhesive Buccal Tablets HPMC K15M, Sodium alginate, Carbopol 940,Talc, MCC, MG sterate Direct Compression 57
12 Mucoadhesive microspheres Carbapol, HPMC K100, Xanthum gum, Guar gum, Calcium Chloride, water, Sodium Alginate Ionotropic gelation 58
13 Nanoemulsion Capryol 90 31, Tween 20,

Transcutol P, Water

 Aqueous Phase Titration 59
14 osmotic tablet Sucrose, Mannitol, MCC, PVP, Starch, Magnesium stearate, Cellulose acetate, methanol. Wet granulation 60
15 polymeric nanoparticles Dichloromethane (DCM), Acetone, PVA, Eudragit RL100 solvent evaporation 61
16 Proniosomes Maltodextrin, Sorbitol, Mannitol, Span-60 slurry method 62
17 Sustained Release Matrix Hydroxypropylmethylcellulose (HPMC), Carboxy methyl cellulose sodium, Microcrystalline cellulose Direct Compression 63
18 Sustained Release Matrix tab Hydroxypropylmethylcellulose, Ethyl cellulose, Guar gum, Eudragit RS 100 and Xanthan gum. Direct Compression 64
19 Sustained Release Matrix Tab HPMC K4M, K15M, K100M, E15, Sodium  CMC Direct compression 65

CONCLUSION: This article includes review of literature for Glipizide, especially it bears analytical and formulation related information, which is cited in Table 1 - 5. This tabulated information will be definitely helpful for all researchers who are currently working on research projects with Glipizide.

ACKNOWLEDGEMENT: The authors wish thanks to the Principal and Management of Shivnagar Vidya Prasarak Mandal’s College of Pharmacy, Malegaon (Bk), Tal. Baramati, District Pune for providing facilities with enthusiastic environment.

CONFLICT OF INTEREST: Nil.

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    How to cite this article:

    Balkate R, Baokar S, Joshi H and Patil R: The complite review on analytical and formulation techniques of glipizide. Int J Pharm Sci Res 2018; 9(3): 894-01.doi: 10.13040/IJPSR.0975-8232.9(3).894-01.

    All © 2013 are reserved by International Journal of Pharmaceutical Sciences and Research. This Journal licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 3.0 Unported License.

     

Article Information

7

894-901

545

2685

5

English

IJPSR

R. Balkate, S. Baokar, H. Joshi * and R. Patil

Department of Pharmaceutics, Shivnagar Vidya Prasarak Mandal’s College of Pharmacy, Malegaon (Bk), Baramati, Pune, Maharashtra, India.

rashmibalkate@gmail.com

23 June, 2017

01 September, 2017

16 November, 2017

10.13040/IJPSR.0975-8232.9(3).894-01

01 March, 2018

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