Development and Validation of Stability indicating RP-HPLC Method for the simultaneous Estimation of Sitagliptin and Ertugliflozin in bulk and Tablet Dosage Forms
A. Suneetha, V. Mounika, Shaik Mahammad Sajid
Abstract
A new simple, sensitive, accurate, precise and reproducible RP-HPLC method has been developed for the simultaneous estimation of sitagliptin and ertugliflozin in bulk and pharmaceutical dosage form using Inertsil ODS (4.6×150mm, 5μ) column in isocratic mode. The mobile phase consisted 0.1% TFA: Methanol: Acetonitrile (30: 60: 10). The detection was carried out at 250nm. The method was linear over the concentration range for sitagliptin 40–200μg/ml and for ertugliflozin 6–30μg/ml. The recoveries of sitagliptin and ertugliflozin were found to be 100.26 and 100.18% respectively. The validation of method was carried out utilizing ICH guidelines. The described HPLC method was successfully employed for the analysis of pharmaceutical formulation containing combined dosage form.