DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING RP- HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF SAXAGLIPTIN AND DAPAGLIFLOZIN IN BULK AND TABLET DOSAGE FORM

Abstract

A novel rapid, sensitive and reproducible stability-indicating RP-HPLC method has been developed and validated for quantitative analysis of Saxagliptin and Dapagliflozin in bulk drug and pharmaceutical dosage form. Chromatographic separation was achieved on Thermo C₁₈ analytical column (250mm×4.60 mm, 5.0μm) with 20mM KH₂PO₄: acetonitrile 35:65 v/v as isocratic mobile phase enabled separation of the drug from its degradation products. UV detection was performed at 252 nm. The method was validated for linearity, accuracy (recovery), precision, specificity and robustness. The linearity of the method was satisfactory over the range 1-5µg/ml for SAXA and 2-10 µg/ml for DAPA with correlation coefficient 0.998, 0.999 for SAXA & DAPA respectively. The limits of detection and quantification of SAXA and DAPA were 0.45,1.20 and  0.52 ,1.53 μg/ml respectively. Recovery of SAXA and DAPA from the pharmaceutical dosage form ranged from 98.13-99.75 and 98.57-99.26% respectively. SAXA and DAPA were subjected to stress conditions (hydrolysis (acid, base), oxidative, photolytic, and thermal degradation) and the samples were analyzed by this method.

Keywords: Saxagliptin and Dapagliflozin, RP-HPLC, Forced degradation, Method validation