Volume - 13 | Issue-1
Volume - 13 | Issue-1
Volume - 13 | Issue-1
Volume - 13 | Issue-1
Volume - 13 | Issue-1
The objective of the study was to develop a reliable and consistent stability indicating RPHPLC method for simultaneous determination of Dapagliflozin and Vildagliptin. By Utilizing a mobile phase of 0.05 M KH2PO4: Acetonitrile: Methanol (pH 6.13) (35:10:55% v/v/v), and detecting at 220 nm, the chromatographic separation of Dapagliflozin and Vildagliptin was achieved on an Anachrom Cosmosil C18 (250 × 4.6 mm. 5 µm) Column. The column temperature was maintained at 35°C, and the flow rate set a 1 ML/min. Retention times of 7.97 and 2.91 min were determined for Dapagliflozin and Vildagliptin, respectively. The developed method exhibited linearity, as evidenced by the regression analysis, which showed a strong correlation with a linear curve within the concentration range of 1-5 µg ml-1 for Dapagliflozin and 10-50 µg ml-1 for Vildagliptin. Forced deterioration experiments were carried out under various conditions, including thermal, photolytic, oxidative, acidic and basic environments. In accordance with ICH guidelines, the method’s robustness, accuracy, precision, linearity, limit of detection, and specificity were all evaluated. Its adaptability, accuracy, and high precision make the developed method suitable for routine analysis of bulk and dosage forms.