Abstract

DEVELOPMENT AND VALIDATION OF ANALYTICAL METHODS FOR SIMULTANEOUS ESTIMATION OF DAPAAGLIFLOZIN PROPANEDIOL MONOHYDRATE AND VILDAGLIPTIN IN TABLET DOSAGE FORM

Riya Upadhyay*, Khyati Patel and Dr. Umesh Upadhyay

ABSTRACT

UV Spectroscopy method is simple and sensitive first order derivative method was developed for the simultaneous estimation of Dapagliflozin Propanediol Monohydrate and Vildagliptin in their tablet dosage form. Developed methods were successfully applied to tablet dosage form and assays were found to be 99.98% for Dapagliflozin Propanediol Monohydrate and 99.53% for Vildagliptin. Simple and sensitive RP-HPLC was developed for simultaneous estimation of Dapagliflozin Propanediol Monohydrate and Vildagliptin in their tablet dosage form. RP-HPLC method was developed using Shimpack ODS C18 column 25 cm (4.6 mm x 250mm, 5 um) as a stationary phase and Acetonitrile: Methanol: Water (20:40:40 % V/V/V) as mobile phase. The flow rate was maintained at 1 mL/ min and detection was carried out at 245 nm where Dapagliflozin Propanediol Monohydrate and Vildagliptin have significant absorbance. The retention times of Dapagliflozin Propanediol Monohydrate and Vildagliptin was found to be 6.865 min and 11.759 min respectively. RP-HPLC method is linear by plotting a calibration curve over the concentration range of 2-6 μg/ ml for DAPA and 40-120 μg / ml for VILD, respectively with R2 - 0.9990 for DAPA and 0.9994 for VILD. The method was found to be accurate, precise, specific, selective, repeatable, robust, and reproducible.

Keywords: Uv, Hplc, Validation, Development .