Determination of ertugliflozin in pharmaceutical formulations by RP-HPLC method

A novel, specific, accurate, rugged, precise reversed-phase high performance liquid chromatography (RP-HPLC) method has been developed for the quantitative determination of Ertugliflozin in active pharmaceutical ingredients and in its Pharmaceutical dosage form by using Symmetry ODS C18 (4.6×250mm, 5µm) column with a mobile phase containing a mixture of Methanol: Phosphate Buffer pH-3.6 in the ratio of 35:65%v/v. The flow rate was 1.0 ml/min and effluent were monitored at 235 nm and a peak eluted at 2.552 min and column oven temperature was maintained ambient. Calibration curve was plotted with a range from 6-14 µg/ml. The LOD and LOQ values of Ertugliflozin were found to be 1.2µg/ml and 3.6µg/ml respectively. The percentage recovery of the Ertugliflozin was found to be within the limits. The developed RP-HPLC method was validated according to the current International Conference on Harmonization (ICH) guidelines for specificity, LOD, LOQ, linearity, accuracy, precision, intermediate precision and robustness. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of Ertugliflozin in bulk drug and in its pharmaceutical dosage form. The proposed method was applied for the analysis of tablet formulations, to improve QC and assure therapeutic efficacy.