ISSN : 2663-2187

Forced Degradation Studies for Determination of Vildagliptin in Pharmaceutical Dosage Forms by RP-HPLC

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Rohit R. Sawant, Kaushal K. Chandrul, Yogesh D. Pawar3
» doi: 10.48047/AFJBS.6.2.2024.4712-4717

Abstract

Vildagliptin which is DPP-4 inhibitor. The aim of the present study was to develop a simple, precise and stability-indicating HPLC method was developed and validated for the determination of Vildagliptin (VLG) in pharmaceutical dosage forms. In RP-HPLC method, the analytes were resolved using Buffer pH 3.0 and (ACN : Methanol) in the ratio of 80:19:1as mobile phase at a flow rate of 1.2 ml/min, on HPLC water 2469 system containing of UV/PDA- detector with empower pro software and Waters X Bridge, C8 column, 150 x 4.6 mm, 5 µm. The detection was carried out at 210 nm for the drug. The method was successfully validated in accordance to ICH guidelines acceptance criteria for specificity, linearity, accuracy, precision, robustness, and system suitability. Forced Degradation studies revealed that the method was found to be stability-indicating. The results showed that the proposed method is suitable for the precise and accurate determination of Vildagliptin in bulk and its formulation.

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