Abstract

DEVELOPMENT AND VALIDATION OF RP - HPLC METHOD FOR THE ESTIMATION OF VILDAGLIPTIN IN PHARMACEUTICAL DOSAGE FORMS

Praveencumar Ramachandra*, Mahalingam Vasudevan, Deecaraman, Ravandur Shivanna Chandan

ABSTRACT

A simple, accurate, precise and rapid RP - HPLC method was developed for the determination of Vildagliptin in Pharmaceutical dosage forms. The chromatographic separation of Vildagliptin was achieved on a symmetry C18, (150 x 4.6mm, 3.5μ) column using UV detector at 220 nm. The mobile phase for this optimized isocratic method consists of Methanol and 10 Mm Ammonium Acetate buffer in the ratio of 30:70. The flow rate was 1 mL/min. The chromatogram showed peak of Vildagliptin at retention time of 5.8 min. The method was validated according to ICH guidelines. The Linearity range was found to be 50-150 μg/mL. The LOD was found to be 2.3 μg/mL and LOQ 5.2 μg/mL for the estimation of Vildagliptin. Recovery of Vildagliptin was found to be between 99.0-99.3%. The proposed method were found to be linear, precise, accurate, specific and all proved to be sensitive, convenient and effective for the determination of Vildagliptin in bulk and pharmaceutical dosage forms.

Keywords: Vildagliptin, RP - HPLC, ICH guidelines.