Abstract :
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.
Keyword :
Ertugliflozin and Sitagliptin, RP-HPLC Method, Simultaneous estimation, Validation as per ICH guidelines, Forced degradation studies.