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 x 250 mm; 5 m), 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.
Keywords: Atorvastatin, ezetimibe, ICH guideline, RP-HPLC.
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