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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

[ Vol. 11 , Issue. 4 ]

Author(s):

S. Ashutosh Kumar, Manidipa Debnath and J. V. L. N. Seshagiri Rao   Pages 259 - 270 ( 12 )

Abstract:


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.

Affiliation:

Department of Pharmaceutical Analysis & Quality Assurance, A.K.R.G College of Pharmacy, Nallajerla, West Godavari, 534112, A.P, India.



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