Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR QUANTITATIVE ESTIMATION OF SITAGLIPTIN PHOSPHATE IN BULK AND PHARMACEUTICAL DOSAGE FORMS

M. Phanisri*, M. Jhansi Lakshmi, D. Rama Brahma Reddy and H. Padmalatha

Abstract

A simple and rapid reversed phase-high performance liquid chromatographic method was developed for simultaneous determination of Sitagliptin Phosphate In Bulk And Pharmaceutical Dosage forms. The elution was done with a mobile phase of Methanol, Acetonitrile & 0.1% ortho phosphoric acid in the ratio of 40:55:05 & adjust to pH 4.1 by using triethyl amine on Zodiac C18 column (250 × 4.6 mm, 5μ). The wavelength of detector was set at 265 nm. The reliability and analytical performance of the proposed HPLC procedure were statistically validated according to the respect of linearity, ranges, precision, accuracy, repeatability, reproducibility, detection and quantification limits. Linear ranges were established between 60-210 μg/mL for the drug. The LOD and LOQ for Sitagliptin was found to be 0.05, 0.16 respectively. The described High Performance Liquid Chromatography method was successfully employed for the analysis of pharmaceutical formulations.

Keywords: Sitagliptin, RP- HPLC, validation, UV Detection, Zodiac C18 column.