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Development and Validation of RP-HPLC method for the estimation of Sitagliptin Phosphate in Bulk and its Tablet Dosage Form


R. Lavanya , Md. Yunoos

Abstract

A new simple and precise reverse phase high performance liquid chromatographic method has been developed and subsequently validated for the estimation of Sitagliptin phosphate monohydrate in bulk and its pharmaceutical dosage form. The chromatographic separation was performed by using mobile phase consisting of 0.01M KH2PO4: Methanol in the ratio of 50:50 % v/v and the pH 2.5 adjusted with 0.2% orthophosphoric acid. The column used was Zorbax Eclipse XDB C18 (150×4.6 mm, 5μ) with flow rate of 0.7 ml/min using PDA detection at 267 nm. The described method was found to be linear over the range of 5- 30μg/ml and correlation coefficient was found to be 0.999. The assay of Sitagliptin was found to be 99.89 %. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise, reliable, accurate and economical which is useful for the routine determination of Sitagliptin phosphate in bulk and its pharmaceutical dosage form.



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