Optimization and Validation of HPLC Method for Simultaneous Determination of Vildagliptin, Pioglitazone Hydrochloride and Glimepiride in Bulk and Tablets

Amin, Muhammad; Abdel‐Aziz, Salah A.; Mostafa, Samia M.; El-Adl, Sobhy M.

doi:10.9790/3008-1202041827

Cited by 8 publications

(3 citation statements)

References 15 publications

(12 reference statements)

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“…Telmisartan and pioglitazone were simultaneously separated using ODS-3v column with 65% of ammonium dihydrogen phosphate buffer (pH 4.5) and 35% of acetonitrile as mobile phase and the retention times were found to be 2.38 min (telmisartan) and 3.16 min (pioglitazone), respectively [17]. Glimepiride, vildagliptin, and pioglitazone hydrochloride were estimated using HPLC coupled to UV detector, where the separation was achieved using Hypersil GOLD C 18 reverse phase column with 45% of acetonitrile and 55% of 0.05 M potassium dihydrogen phosphate buffer as eluent, and the retention times were found to be vildagliptin (1.27 min), pioglitazone hydrochloride (2.71 min), and glimepiride (8.87 min) respectively [18]. In another study, the separation of pioglitazone hydrochloride and glimepiride analytes was done by HPLC using reversed phase C 18 (ODS) column with mobile phase potassium dihydrogen phosphate buffer (pH 3.4) and acetonitrile (40:60 v/v) and the retention times were found to be 4.5±0.1 min (pioglitazone) and 10.0±0.1 min (glimepiride) [19].…”

Section: Analysis Using High-performance Liquid Chromatography (Hplc)mentioning

confidence: 99%

Assessment of Chromatographic Separations for Antihypertensive and Antidiabetic Drugs

Venkataraman

2018

Asian J Pharm Clin Res

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Context: The focus of this review is to compile the different chromatographic methods that were reported earlier for the analysis of different antihypertensive and antidiabetic drugs. Objective: The magnitude of chemical entities investigated and entering into the medicinal field for various health-related ailments is escalating year after year. The drugs are either innovative entities or fractional structural variation of the preexisting chemical molecule. These drugs may exhibit unexpected toxicities after Phase IV of clinical trials, resulting in their withdrawal from the market. Under these circumstances, analytical measures for these drugs may not be accessible in the pharmacopeias. The main aim of this work is to compile the different analytical techniques for the quantification of various antihypertensive drugs and antidiabetic drugs. Methods: The present work is to thoroughly study the literature for the application of different analytical techniques such as high-performance liquid chromatography (HPLC) and liquid chromatography-mass spectroscopy/tandem mass spectroscopy (LC-MS/MS) for the quantification of antihypertensive drugs and anti-diabetic drugs. Results: The present study attempts to collate various analytical techniques that were developed and validated for the estimation of few important antidiabetic and antihypertensive drugs either in pure, individually or combined with other pharmaceutical dosage form by HPLC, LC-MS/MS, and high-performance thin-layer chromatography techniques. Conclusion: Different chromatographic methods are considered to be rapid tools for qualitative and quantitative analysis of newer chemical entities in pharmaceuticals. The amount of these newer chemical entities which are reaching the pharmaceutical market is increasing day by day nevertheless there exists a lag in establishing the standard protocols for the identification, impurity profiling, related substance and assay method. Hence, the present review compiles the different analytical methods that were reported in the literature and thus helps the researchers and chemists to make use of the analytical techniques for the quantification and validation of various antidiabetic and antihypertensive drugs.

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Section: Analysis Using High-performance Liquid Chromatography (Hplc)mentioning

confidence: 99%

Assessment of Chromatographic Separations for Antihypertensive and Antidiabetic Drugs

Venkataraman

2018

Asian J Pharm Clin Res

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“…Different analytical methods have been published for the determination of GLM and PIO either alone or in combination including spectrophotometric [4][5][6][7], spectrofluorometric [8], HPLC [1,[9][10][11][12][13][14][15], TLC [1,16,17]. Several methods have been used for determination of VAL [2,[18][19][20][21][22][23][24][25][26][27], whereas ATV was determined by spectrophotometric [3,28], spectrofluorometric [29], HPLC [24,[30][31][32], TLC [33]and electrochemical [34] methods.…”

Section: Introductionmentioning

confidence: 99%

Eco-friendly micellar ultra-performance liquid chromatography (UPLC) method for simultaneous determination of non-communicable diseases drugs in bulk powder, spiked human plasma and in individual dosage forms

Fouad,

Rashed,

Hosameldin

2024

Journal of advanced Biomedical and Pharmaceutical Sciences

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Green, simple and accurate micellar UPLC method was established and validated for quantitative determination of glimepiride, pioglitazone HCl, Valsartan and atorvastatin calcium trihydrate in bulk powder, tablets and spiked human plasma. Gradient separation was achieved on Kinetex 1.7µ C18 100A (2.1-mm × 50-mm) at ambient temperature using ecofriendly gradient mobile phase composed of a mixture of 0.05 M potassium dihydrogen phosphate buffer pH 5.00 (A) with 0.10M sodium dodecyl sulfate and isopropanol (15.00-25.00%) (B) at flow rate of 0.20 mL/minute and UV detection at 230.00 nm using metformin as internal standard. The method was linear in the range of 0.50-25.00 μg/mL. The proposed method was effectively applied for the determination of glimepiride, pioglitazone HCl, valsartan and atorvastatin in bulk powder, pharmaceutical dosage forms and human plasma with good accuracy and precision. The results were compared with those of the reported methods and were found to be in good agreement. The proposed method was validated according to ICH guidelines.

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“…Literature data reports a few chromatographic methods for the simultaneous determination of VLD with GLM or PIO in bulk and commercially available drug products [ 33 , 34 ]. Interestingly, none of the previous methods reported the simultaneous estimation of the studied drugs.…”

Section: Introductionmentioning

confidence: 99%

Earth-friendly micellar UPLC technique for determination of four hypoglycemic drugs in different pharmaceutical dosage forms and spiked human plasma

et al. 2023

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A novel, sensitive, and green micellar UPLC method was proposed and validated for the simultaneous determination of four hypoglycemic agents used in type II diabetes mellitus treatment namely, pioglitazone, alogliptin, glimepiride, and vildagliptin. The developed UPLC method was successfully applied for quantitative analysis of these drugs in bulk, in pharmaceutical formulations, and in spiked human plasma. Chromatographic separation was carried out on a Kinetex® 1.7 μm XB-C18 100 Å (50 × 2.1 mm) column, using a degassed and filtered mixture of (0.1 M SDS- 0.3% triethyl amine- 0.1% phosphoric acid (pH 6)) and n-propanol (85:15 v/v), at a flow rate of 0.2 mL/min. The experimental conditions of the suggested method were well investigated and optimized. The newly developed micellar UPLC method is capable of determining different dosage forms at the same time with the same solvents, saving time and effort. The method was found to be efficiently applicable in spiked human plasma and could be extended to study the pharmacokinetics of the cited drugs in real human plasma samples. The greenness of the developed method was evaluated by applying the Eco-scale scoring tool, which verified the excellent greenness of the analytical method.

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Optimization and Validation of HPLC Method for Simultaneous Determination of Vildagliptin, Pioglitazone Hydrochloride and Glimepiride in Bulk and Tablets

Cited by 8 publications

References 15 publications

Assessment of Chromatographic Separations for Antihypertensive and Antidiabetic Drugs

Assessment of Chromatographic Separations for Antihypertensive and Antidiabetic Drugs

Eco-friendly micellar ultra-performance liquid chromatography (UPLC) method for simultaneous determination of non-communicable diseases drugs in bulk powder, spiked human plasma and in individual dosage forms

Earth-friendly micellar UPLC technique for determination of four hypoglycemic drugs in different pharmaceutical dosage forms and spiked human plasma

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