title: 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.
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 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.
authors.affiliation: Department of Pharmaceutical Analysis & Quality Assurance, A.K.R.G College of Pharmacy, Nallajerla, West Godavari, 534112, A.P, India. ashu.mpharm2007@gmail.com.
authors.forename: S Ashutosh
authors.initials: SA
authors.lastname: Kumar
authors.forename: Manidipa
authors.initials: M
authors.lastname: Debnath
authors.forename: J V L N
authors.initials: JV
authors.lastname: Seshagiri Rao
mesh_terms: D000069059:Atorvastatin / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid; D056148:Chromatography, Reverse-Phase; D000069438:Ezetimibe / Q000032:analysis*; D057230:Limit of Detection; D011208:Powders; D013607:Tablets
chemical_list: D011208:Powders; D013607:Tablets; D000069059:Atorvastatin; D000069438:Ezetimibe