Volume No. :   10

Issue No. :  2

Year :  2020

ISSN Print :  2231-5667

ISSN Online :  2231-5675


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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



Address:   A. Suneetha*, V. Mounika, Shaik Mahammad Sajid
Department of Pharmaceutical Analysis, Hindu College of Pharmacy, Amaravathi Road, Guntur, A.P India.
*Corresponding Author
DOI No: 10.5958/2231-5675.2020.00014.9

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.
KEYWORDS:
Ertugliflozin, RP HPLC, Sitagliptin, ICH guidelines.
Cite:
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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