New validated RP-HPLC analytical method for simultaneous estimation of atorvastatin and ezetimibe in bulk samples as well in tablet dosage forms by using PDA detector

摘要

This paper describes a new RP-HPLC method for simultaneous quantification of these compounds in the bulk sample drug as well as in tablet dosage forms. The chromatographic separation was performed on an XTerra C8 (4.6 × 250 mm; 5 μm), with phosphate buffer [pH 3.5] and acetonitrile in the ratio of 40:60 (v/v) as mobile phase. The detection was carried out at 240 nm. The accuracy was found to be 99.59 % and 98.98 % for atorvastatin and ezetimibe respectively. The linearity was 5-25 μg/ml for both the drugs. The intra-day RSD was 0.57% and inter-day RSD was 0.13% for atorvastatin calcium and intra-day RSD was 0.56% and inter-day RSD was 0.09% for ezetimibe. The validation of method was carried out utilizing ICH-guidelines.