A NEW STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ERTUGLIFLOZIN AND SITAGLIPTIN IN BULK AND PHARMACEUTICAL DOSAGE FORM ITS VALIDATION AS PER ICH GUIDELINES

A new RP-HPLC method for the quantitative determination of Ertugliflozin and Sitagliptin was developed and validated as per ICH guidelines. The drugs were injected into Std Azilent column (150×4.6, 5 μm), maintained at ambient temperature and effluent monitored at 240 nm.The mobile phase consisted of Buffer (Potassium di hydrogen Ortho Phosphate): Acetonitrile (70:30 V/V). The flow rate was maintained at 1.0 ml/min. The calibration curve for Ertugliflozin and Sitagliptin were linear from 3.75-22.5μg/ml and 25-150μg/ml respectively (r2 for Ertugliflozin = 0.9992,r2 for Sitagliptin = 0.9995). Retention time was 3.203min (Ertugliflozin), 2.106min (Sitagliptin ). Accuracy was in the range of 99.67-99.90% for both drugs. Precision was 0.1% and 0.2% for Ertugliflozin and Sitagliptin, LOD and LOQ are 0.43ug/ml and 1.31ug/ml for Ertugliflozin and , 0.74ug/ml and 2.24ug/ml for Sitagliptin. The proposed method was adequate, sensitive, reproducible, accurate and precise for the determination of Ertugliflozin and Sitagliptin in bulk and pharmaceutical dosage forms. When applied for tablet assay, drug content was within 99.18.-99.13 % of labeled content. Forced degradation studies indicated the suitability of the method for stability studies. Keywords: Ertugliflozin and Sitagliptin, RP-HPLC Method, Simultaneous estimation, Validation as per ICH guidelines, Forced degradation studies.