Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING METHOD FOR THE SIMULTANEOUS ESTIMATION OF SAXAGLIPTIN HYDROCHLORIDE AND DAPAGLIFLOZIN USING RPHPLC METHOD IN TABLET DOSAGE FORM

Dr. Advaita B. Patel*, Dr. Deepa R. Patel and Zarna Shah

ABSTRACT

A simple, rapid, precise, accurate and robust stability-indicating RP-HPLC method has been developed and validated to estimate Saxagliptin hydrochloride and Dapagliflozin in bulk and in tablet form. The samples were isocratically eluted using a C18 (25cm x 0.46 cm) Inertsil ODS column with mobile phase Potassium dihydrogren phosphate Buffer (pH 6.0): Acetonitrile (45:55 v/v) at wavelength 220 nm. A good linear response was obtained in the range from 56-84 μg/ml of Saxagliptin hydrochloride and 112-168 μg/ml of Dapagliflozin. The method was quantitatively evaluated in terms of linearity, precision, accuracy (recovery), selectivity and robustness as per ICH guideline. Forced degradation conditions of hydrolysis (neutral, acidic and alkaline), oxidation, photolysis and thermal stress, as suggested in the ICH guideline Q1A (R2) were estimated. The drug showed instability in hydrolysis (neutral, acidic and alkaline), oxidation, photolysis and thermal stress conditions.

Keywords: RP-HPLC, Saxagliptin Hydrochloride, Dapagliflozin, ICH Guideline.