A SENSITIVE RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF ATORVASTATIN CALCIUM, FENOFIBRATE, AND ORLISTAT IN TABLET DOSAGE FORM
Journal Title: Int J of Preclin & Pharm Res - Year 2014, Vol 4, Issue 1
Abstract
ABSTRACT A simple, sensitive and reproducible method was developed and validated for the simultaneous estimation of Atorvastatin calcium, Fenofibrate, and Orlistat in tablet formulation by reverse phase high performance liquid chromatography by using HPLC Prominance / shimadzu (Isocratic system) with Biochrom – Double beam UV-VISIBLE spectrophotometer at the λmax of 210 nm, using Zorbax C8(250 x 4.6), 5 µm. The mobile phase used as Phosphate buffer (pH 6.8): Acetonitrile: Water: Phosphoric acid (850:150:0.05) with isocratic flow (flow rate 1.0 ml/min) and the pH was adjusted with phosphate buffer. Mobile phase is used as diluent. The compounds Atorvastatin calcium, Fenofibrate, and Orlistat were eluted at 2.78, 4.62 and 10.27 min respectively. The peaks were eluted with better resolution. The sample concentrations are measured on weight basis to avoid the internal standard. The method is validated and shown to be linear. The correlation coefficients for Atorvastatin, Fenofibrate and Orlistat are 0.999, 0.989 and 0.999, respectively. The relative standard deviation for six replicates is always less than 2%. This HPLC method is successfully applied to the simultaneous quantitative analysis of the drugs in tablets. Keywords: C8 column, Atorvastatin calcium, Fenofibrate, Orlistat, RP-HPLC, Method Validation.
Authors and Affiliations
V. Mani Deepika*, J. Rudraprasad Reddy , K. M. Ch Appa Rao , D. Peer Basha*
Keywords
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- EP ID EP154219
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