Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLCMETHOD FOR SIMULTANEOUSESTIMATION OF DAPAGLIFLOZIN AND VILDAGLITPININ TABLET DOSAGE FORM

Krunal Yagnik* and Priyanka Yadav

ABSTRACT

A Specific, sensitive, accurate, precise and robust gradient RP- HPLC method was Developed and validated for Dapagliflozin and Vildagliptin, using Zorbex C18 (250mm*4.6mm) 5μm column with flow rate 1.0ml/min and Detection Wavelength of 215 nm. The mobile phase is Buffer pH 5.8: ACN (20:80%v/v) and injection volume is 20μl, total run time 15 min. Detection carried out at 215nm wavelength. The stability indicating capability of method was established by forced degradation studies of bulk and pharmaceutical dosage form. The developed method was validated as per International Conference of Harmonization (ICH) specificity, linearity, accuracy, precision, robustness, limit of detection, and limit of quantification. Stability Indicating Study suggested that major degradation of bulk was observed in Thermal condition and form was observed in Oxidative condition. Correlation co-efficient for calibration curve of Dapagliflozin and Vildagliptin was found to be 0.999. The RSD for precision and robustness was found less then.

Keywords: Dapagliflozin, Vildagliptin, RSD (Relative Standard Deviation.