UV SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF SITAGLIPTIN PHOSPHATE IN BULK AND TABLET DOSAGE FORM BY ABSORPTION RATIO AND AREA UNDER THE CURVE METHOD
Journal Title: Journal of Biological and Scientific Opinion - Year 2013, Vol 1, Issue 4
Abstract
To develop two simple UV spectrophotometric methods for simultaneous estimation of Sitagliptin phosphate (STG) in bulk and tablet dosage forms and validates as per ICH guidelines. Method A involved Absorbance maxima method which based on the measurement of absorbance at λ max of Sitagliptin phosphate 267 nm and Method B involved Area under the curve (AUC) method which based on the measurement of AUC in the range of 261-270 nm. The developed methods were validated for linearity, precision, accuracy, LOD and LOQ as per ICH guidelines. Both the methods were found to be linear within the conc. range of 20-160 µg/ml for Sitagliptin phosphate. The present methods were found to be simple, linear, precise, accurate and sensitive and can be used for routine quality control analysis for the estimation of Sitagliptin phosphate in bulk and tablet dosage form.
Authors and Affiliations
Vinit Chavhan, Atul Kadam
Keywords
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- EP ID EP99134
- DOI 10.7897/2321–6328.01407
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