A Validated Reversed-Phase HPLC Method for the Determination of Vildagliptin from Tablet Dosage Form

Khatun, Rahima; Mirazzunnabi,

doi:10.3329/ijpls.v2i3.15455

Cited by 7 publications

(4 citation statements)

References 3 publications

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“…The results indicated that there is no significant variation between the proposed methods and the reference method with respect to accuracy and precision. [23]; 10, 11 reference method [30]; 18 reference method [54], 19 reference method [55], 20, 22 reference method [56].…”

Section: Application Of the Methods To Pharmaceutical Formulationsmentioning

confidence: 99%

Rapid and Simultaneous Analysis of Seven Oral Anti-Diabetic Drugs

2020

JJC

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The present study describes the optimization and validation of a high-performance liquid chromatographic (HPLC) method for the determination of seven medicines (Metformin hydrochloride, Vildagliptin, Gliclazide, Sitagliptin phosphate, Pioglitazone hydrochloride, Glibenclamide and Glimepirde) in bulk and pharmaceutical dosage forms. The chromatographic separation could be achieved using a C8 column (100 Å, 5 µm, 150 mm) at 30 °C. Thereby, the mobile phase is a mixture of acetonitrile and an aqueous solution of triethylamine (0.5% v/v) and phosphoric acid 10% w/v (pH 7.0) at a mixing ratio of 32.5:67.5 v/v%, with a flow rate of 1.0 ml/min and detection performed at 210 nm using a UV detector. The results were found satisfactory and the method can be adapted to routine quality control of medications as recommended by the guidelines of the International Conference on Harmonization.

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Section: Application Of the Methods To Pharmaceutical Formulationsmentioning

confidence: 99%

Rapid and Simultaneous Analysis of Seven Oral Anti-Diabetic Drugs

2020

JJC

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“…The market is flooded with many drugs for the management of diabetes and it is also prime requirement to have quality medicines a patient have to get relief from increase glucose level. Several methods available to estimate Vildagliptin (VIL) and Dapagliflogin (DAP) by using UV Spectroscopy [1][2][3][4][5], UPLC [6], RP-HPLC [7][8][9][10][11][12][13], UPLC and LC-MS/MS [14][15][16] in individual dosage form and combination with Metformin and Saxagliptin. In the current scenario, regulatory authority also recommend manufacturer to have quantitative and qualitative estimation by sophisticated instrument HPLC.…”

Section: Introductionmentioning

confidence: 99%

Simultaneous Estimation and Stability Indicating Method of Vildagliptin And Dapagliflozin by RP-HPLC in Pharmaceutical Dosage Form

2024

Int Internal Med J

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Vildagliptin and Dapagliflozin drugs are used for the management of diabetes.The primary objective of the proposed research was to develop and validate analytical methods for simultaneous quantification of vildagliptin and dapagliflozin in pharmaceutical dosage form. Both the drugs were subjected to force degradation to ensure stability of pharmaceutical products. The HPLC method development was carried out on C18 column (250mm*4.6mm,5µm particle size). The chromatographic separation was achieved by isocratic mode with a mixture of Methanol: 0.01% Trifluoro acetic acid (pH-2.78) in the ratio of 95:05 % v/v as mobile phase. Flow rate was kept at 0.8 ml/min and selected wavelength for estimation was 210 nm. Stress testing with acid, alkaline, oxidative and thermal degradation was performed. The retention time was found to be 2.282 min and 4.070 min for vildagliptin and dapagliflozin, respectively. The drugs response found to be linear with correlation coefficient value was nearly 0.999 for vildagliptin and dapagliflozin with linearity range of 10 – 60 µg/ml. The recoveries from studies were found to be 99.78% and 100.17% for vildagliptin and dapagliflozin respectively. LOD and LOQ were found to be lower, hence the method proved sensitivity. Method was validated as per ICH guideline Q2(R1). Drugs had shown more degradation in oxidative condition, 10.62% and 13.52% for vildagliptin and dapagliflozin, respectively. The proposed method would be successfully applied for the stability indicating, impurity separation, qualitative and quantitative estimation of vildagliptin and dapagliflozin in pharmaceutical dosage form and in process quality control analysis.

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“…[1][2][3] The market is ooded with many drugs for the management of diabetes and it is also prime requirement to have quality medicines a patient have to get relief from increase glucose level. Several methods available to estimate Vildagliptin (VIL) and Dapagli ogin (DAP) by using UV Spectroscopy [1][2][3][4][5], UPLC [6], RP-HPLC [7][8][9][10][11][12][13], UPLC and LC-MS/MS [14][15][16] in individual dosage form and combination with Metformin and Saxagliptin. But, no single method was available for simultaneous determination and stability indicating assay method of VIL and DAP by RP HPLC.…”

Section: Introductionmentioning

confidence: 99%

Simultaneous Estimation and Stability Indicating Method of Vildagliptin and Dapagliflozin by Rp-hplc in Pharmaceutical Dosage Form

Patel,

Teraiya

2024

Preprint

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Vildagliptin and Dapagliflozin drugs are used for the management of diabetes.The primary objective of the proposed research was to develop and validate analytical methods for simultaneous quantification of vildagliptin and dapagliflozin in pharmaceutical dosage form. Both the drugs were subjected to force degradation to ensure stability of pharmaceutical products.The HPLC method development was carried out on C18 column (250mm*4.6mm,5µm particle size). The chromatographic separation was achieved by isocratic mode with a mixture of Methanol: 0.01% Trifluoro acetic acid (pH-2.78) in the ratio of 95:05 % v/v as mobile phase. Flow rate was kept at 0.8 ml/min and selected wavelength for estimation was 210 nm. Stress testing with acid, alkaline, oxidative and thermal degradation was performed. The retention time was found to be 2.282 min and 4.070 min for vildagliptin and dapagliflozin, respectively. The drugs response found to be linear with correlation coefficient value was nearly 0.999 for vildagliptin and dapagliflozin with linearity range of 10 – 60 µg/ml. The recoveries from studies were found to be 99.78% and 100.17% for vildagliptin and dapagliflozin respectively. LOD and LOQ were found to be lower, hence the method proved sensitivity. Method was validated as per ICH guideline Q2(R1). Drugs had shown more degradation in oxidative condition, 10.62% and 13.52% for vildagliptin and dapagliflozin, respectively. The proposed method would be successfully applied for the stability indicating, impurity separation, qualitative and quantitative estimation of vildagliptin and dapagliflozin in pharmaceutical dosage form and in process quality control analysis.

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A Validated Reversed-Phase HPLC Method for the Determination of Vildagliptin from Tablet Dosage Form

Cited by 7 publications

References 3 publications

Rapid and Simultaneous Analysis of Seven Oral Anti-Diabetic Drugs

Rapid and Simultaneous Analysis of Seven Oral Anti-Diabetic Drugs

Simultaneous Estimation and Stability Indicating Method of Vildagliptin And Dapagliflozin by RP-HPLC in Pharmaceutical Dosage Form

Simultaneous Estimation and Stability Indicating Method of Vildagliptin and Dapagliflozin by Rp-hplc in Pharmaceutical Dosage Form

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