Abstract

Ushma Jani, Dr. Bhumi R. Patel*, Dr. Jaymin G. Patel, Janki Patel, Mr. Ronak N. Patel, Ms. Mugdha Dhimar

ABSTRACT

A simple, precise, accurate, and stability-indicating RP-HPLC method was successfully developed and validated for the simultaneous estimation of Dapagliflozin Propanediol and Eplerenone in a synthetic mixture. Chromatographic separation was achieved using a Cosmosil C18 column (250 mm ×4.6 mm, 5µm) with a Isocratic mobile phase of buffer and methanol (30:70%v/v), at a flow rate of 1.0 mL/min and detection at 228 nm. The developed RP-HPLC method showed excellent performance with good chromatographic separation of Dapagliflozin Propanediol and Eplerenone. The method exhibited strong linearity in the ranges of 10-30 ppm for Dapagliflozin and 25-75 ppm for eplerenone, with correlation coefficients exceeding 0.999. Validation studies, conducted in accordance with the International Council for Harmonization (ICH) Q2(R2) guidelines, confirmed that the method was precise, accurate, robust, specific, and sensitive. The stability-indicating capability was verified through forced degradation experiments under acidic, alkaline, oxidative, and thermal conditions, where degradation products were adequately resolved from the parent compounds using the developed method. The validated method was successfully applied to the analysis of a synthetic mixture, yielding assay results of 100.33% for dapagliflozin and 99.65% for eplerenone. Therefore, the proposed method is suitable for routine quality control analysis and stability studies.