Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE ESTIMATION OF SITAGLIPTIN PHOSPHATE IN BULK AND TABLET DOSAGE FORM

Neha Sunil Dangi*, S. R. Bavaskar and Dr. S. D. Barhate

Abstract

A simple new, precise, economic reverse phase high performance chromatographic method has been developed and validated for the estimation of Sitagliptin phosphate in bulk and tablet dosage form. The estimation is done by using C18 Primesil (250mm x 4.6mm;5μm) column and mobile phase is Methanol: Water (50:50 % v/v), pH is maintained at 3 by using Orthrophosphoric Acid. The chromatographic separation was performed with the UV detector set at 264 nm and flow rate is maintained at 0.7ml/min. The method was validated and found to be linear in the range of 20 - 100 μg/ml and correlation coefficient was found to be 0.999. The assay of Sitagliptin was found to be 99.15%. The results of the study showed that the proposed RP-HPLC method is simple, accurate and economical which is useful for the routine determination of Sitagliptin phosphate in bulk and its pharmaceutical dosage form.

Keywords: Sitagliptin Phosphate, RP-HPLC, Method development, Validation.