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Asian Journal of Pharmaceutical Analysis
ISSN: 2231-5675(Online), 2231-5667(Print)
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Development and Validation of Stability indicating RP-HPLC Method for the simultaneous Estimation of Sitagliptin and Ertugliflozin in bulk and Tablet Dosage Forms
Shaik Mahammad Sajid
A. Suneetha*, V. Mounika, Shaik Mahammad Sajid
Department of Pharmaceutical Analysis, Hindu College of Pharmacy, Amaravathi Road, Guntur, A.P India.
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.
Ertugliflozin, RP HPLC, Sitagliptin, ICH guidelines.
A. Suneetha, V. Mounika, Shaik Mahammad Sajid. Development and Validation of Stability indicating RP-HPLC Method for the simultaneous Estimation of Sitagliptin and Ertugliflozin in bulk and Tablet Dosage Forms. Asian J. Pharm. Ana. 2020; 10(2): 81-85.
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