QUANTITATIVE SIMULTANEOUS DETERMINATION OF FENOFIBRATE, ATORVASTATIN, AND EZETIMIBE IN TABLETS USING GRADIENT HIGH-PERFORMANCE COLUMN LIQUID CHROMATOGRAPHY AND HIGH-PERFORMANCE THIN-LAYER CHROMATOGRAPHY

Abstract

Simple, accurate, precise, sensitive, and validated high-performance liquid chromatography (HPLC) and high-performance thin-layer chromatography (HPTLC)-densitometric methods were developed for simultaneous determination of fenofibrate (FEN), atorvastatin (ATO), and ezetimibe (EZE) in combined tablet dosage form. In Method A, the gradient RP-HPLC analysis was performed on a Shim-pack C18 column (150 × 6 mm id), using a mobile phase consisting of 0.1% formic acid and acetonitrile in solvent gradient elution for 25 min at a flow rate of 1.5 mL min−1. Quantification was carried out using a photodiode array UV detector at 245 nm. The employment of diode array detector allowed selectivity confirmation by peak purity evaluation. In Method B, the HPTLC analysis was carried out on an aluminum-backed sheet of silica gel 60F254 layer using toluene: methanol:triethylamine (8:1.5:0.1, v/v/v) as the mobile phase. Quantification was achieved with UV densitometry at 245 nm. The analytical methods were validated according to International Conference on Harmonization guidelines. Low relative standard deviation values indicated good precision. Both the methods were successfully applied for the analysis of drugs in laboratory-prepared mixtures and commercial tablets. No chromatographic interference from tablet excipients was found, and hence these methods are applicable for simultaneous determination of FEN, ATO, and EZE in pharmaceutical formulations.