Abstract

DEVELOPMENT AND VALIDATION OF RP - HPLC METHOD FOR ESTIMATION OF DAPAGLIFLOZIN AND SPIRONOLACTONE IN SYNTHETIC MIXTURE

Ketul Gajjar*, Dr. Neha Tiwari, Dr. Pragnesh Patani and Dr. Swati Rawat

ABSTRACT

This review article outlines the development and validation of a dependable reverse-phase high-performance liquid chromatography (RP-HPLC) method intended for the simultaneous analysis of Dapagliflozin and Spironolactone in a synthetic mixture. The method was optimized to achieve effective separation and quantification of both compounds by utilizing an appropriate stationary phase and mobile phase composition. Key parameters, including retention time, resolution, and peak symmetry, were thoroughly evaluated to ensure the method's reliability. Validation was performed following ICH guidelines, addressing factors such as specificity, linearity, accuracy, precision, limit of detection (LOD), and limit of quantification (LOQ). The results demonstrated strong linearity within a specified concentration range, as well as acceptable LOD and LOQ values. Overall, the developed RP-HPLC method proved to be efficient, reproducible, and suitable for routine quality control analyses.

Keywords: Dapagliflozin, Spironolactone, Diabetes, Hypertension, RP - HPLC method, Pharmaceutical analysis.