Development of a New Validated Stability Indicating Method for Quantification of Fenofibric acid and Pitavastatin by Ultra Performance Liquid Chromatography

Abstract

The main objective of the present work is to develop an efficient, unique, reliable Ultra performance liquid chromatographic method for the simultaneous quantificaiton of Fenofibric acid and Pitavastatin in bulk and Pharmaceutical formulations. The Chromatographic separation of the selected combination of drugs was performed on a Kinetex C8 column (150mm x4.6mm, 2.6 µ) using an isocratic elution with a buffer containing 0.1% formic acid and acetonitrile at a ratio of 80:20 as a mobile phase with a flow rate of 0.5 mL/min at ambient temperature and wavelength at 266nm.The method produced reliable results at optimised chromatographic conditions. Analysis of honest linearity within a concentration range of 135- 2025 µg/mL of fenofibric acid and 2-30 µg/mL of Pitavastatin with regression coefficients of 0.9992 and 0.9997 respectively was obtained. The retention time for fenofibric acid and pitavastatin were 1.778 min and 3.171 min respectively. LOD and LOQ were found to be 1.35 µg/mL, 0.02 µg/mL and 13.5 µg/mL, 0.2 µg/mL for fenofibric acid and pitavastatin respectively.The proposed method was validated in accordance with the guidelines of the International Council for Harmonization (ICH). All the obtained validation results of the proposed method were found to satisfactory and was succesfully applicable to the analysis of the bulk and the pharmaceutical formulations.