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

Author(s): S. Ashutosh Kumar, Manidipa Debnath, J. V. L. N. Seshagiri Rao

Journal Name: Current Drug Discovery Technologies

Volume 11 , Issue 4 , 2014

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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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Article Details

Year: 2014
Published on: 07 May, 2015
Page: [259 - 270]
Pages: 12
DOI: 10.2174/1570163812666150101154857
Price: $65

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