Development and Validation of stability indicating RP-HPLC method for the estimation of Ertugliflozin by forced degradation studies

Abstract

Background: From the literature survey it was found that stability indicating analytical methods have not been reported for evaluation of Ertugliflozin in drug substance (bulk or API) and on drug product. Objective: Developing and validating stability indicating RP-HPLC analytical method for the estimation of Ertugliflozin. Method: Current study develops a novel analytical method for separating drug from the degradation products that is formed under stress conditionsby utilizing methanol: water as mobile phase in the composition of 90:10 v/v using HiQ Sil C-18 (150×4.6)mm, 5.0µm column usingUV detection at 260 nm and flow rate of 0.7 mL/min. Results: Retention time for Ertugliflozin was observed to be 4.1 min. Ertugliflozin was exposed to stress conditions of hydrolysis (acid and alkali degradation), oxidation, photolysis and neutral decomposition. The developed method was validated taking into reference ICH guidelines. Conclusion: This method can be used routinely in pharmaceutical industries to analyse drugs in pharmaceutical dosage forms.