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Asian Journal of Pharmaceutical Analysis
Year : 2020, Volume : 10, Issue : 2
First page : ( 81) Last page : ( 85)
Print ISSN : 2231-5667. Online ISSN : 2231-5675.
Article DOI : 10.5958/2231-5675.2020.00014.9

Development and Validation of Stability indicating RP-HPLC Method for the simultaneous Estimation of Sitagliptin and Ertugliflozin in bulk and Tablet Dosage Forms

Suneetha A.*, Mounika V., Sajid Shaik Mahammad

Department of Pharmaceutical Analysis, Hindu College of Pharmacy, Amaravathi Road, Guntur, A.P, India

*Corresponding Author E-mail: drasuneetha@gmail.com

Online published on 3 June, 2020.

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.

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Keywords

Ertugliflozin, RP HPLC, Sitagliptin, ICH guidelines.

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