DEVELOPMENT AND VALIDATION FOR EVOGLIPTIN IN BULK AND TABLET DOSAGE FORM USING ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY-PDA METHOD
Authors/Creators
- 1. Netaji Subhas Chandra Bose Institute of Pharmacy, Chakdaha, Nadia, West Bengal, India.
- 2. Institute of Pharmacy & Technology, Salipur, Cuttack, Biju Patnaik University of Technology, Odisha, India.
- 3. School of Pharmacy & Life Sciences, Centurion University of Technology & Management, Bhubaneswar, Odisha, India
Description
Abstract
To develop a novel ultra-performance liquid chromatographic technique for the estimation of evogliptin in a API and tablet. The chromatographic separation was achieved using DIKMA Endoversil (2.1 x 50mm, 1.7µm) column, mobile phase was phosphate buffer, pH 4.2 and acetonitrile as a mobile phase (30:70) with a flow rate of 0.4 mL/min and eluent was monitored at 237 nm. The method was validated in accordance with International conference on harmonization guidelines. In this method evogliptin was eluted with retention time of 0.639 minutes. Calibration curve plots were found linear over the concentration ranges 2-50 μg/mL for evogliptin. Limit of detection was 0.2μg/ml and limit of quantification was found 0.5 μg/mL. The % assay of the marketed dosage form was found 97.8 %, even the present approach was found to be effective in the analysis of evogliptin in force degradation condition the experiential evidences of all the study results revealed the suitability of the estimation of evogliptin in API and tablet formulation.