Development of RP-HPLC Method for Simultaneous Estimation of Atrovastatin and Ezetimibe in Pharmaceutical Formulation

Abstract

A simple, selective, rapid, precise, and cost-effective reverse phase HPLC method for simultaneous estimation of Atrovastatin and Ezetimibe from pharmaceutical dosage forms has been developed. The method was carried out on a Phenomenex C18 (25 cm x 4.6 mm i.d., 5 µ) column with a mobile phase consisting of Water and 0.4% (v/v) TEA: Acetonitrile (adjusted to pH 6.5 using Orthophosphoric acid) (60:40 v/v) at a flow rate of 1 ml/min. The detection was carried out at a wavelength of 248 nm. As an internal control, pioglitazone was used. Atrovastatin, Ezetimibe, and Pioglitazone, respectively, had retention times of 3.42, 6.90, and 4.28 minutes.The accuracy, precision, linearity, limit of detection, limit of quantitation, and solution stability of the established method have all been validated. The suggested method can be used to estimate the dosage forms of these drugs in combination dosage forms. The current RP-HPLC system can be used to check the quality of raw materials, formulations, and dissolution tests.