Abstract

A novel simple, precise, accurate and high resolution and shorter retention time makes this method more acceptable, cost effective and accurate RP-HPLC (Reverse Phase High Performance Liquid Chromatography) method has been developed for the simultaneous estimation of Pravastatin and Fenofibrate in Pharmaceutical dosage forms. The chromatographic separation was achieved on Shimadzu (LC 20 AT VP) Agilent 1200 series HPLC using Inertsil sustain column, C18 (250×4.6mm× 5µm) maintained at ambient temperature with mobile phase consisting of a mixture of Phosphate buffer (KH2PO4) pH 4.5 Methanol: Acetonitrile (40:20:40v/v/v), with detection of 249 nm, flow rate 1.0 ml/min, load volume 20 μl and a run time of 6 min. The UV detection was performed at 229 nm. Buffer was prepared with KH2PO4 and adjusted pH to 4.5 with Ortho-Phosphoric Acid. The retention time and mean recoveries obtained for Pravastatin was 2.190 min and 99.43%, for Fenofibrate was 3.710 min and 99.44% respectively. Linearity response was established over the concentration range of 12-28 μg/ml for Pravastatin and 87-203μg/ml for Fenofibrate. The correlation coefficient for Pravastatin and Fenofibrate was 0.9990 and 0.9993 respectively. The recovery studies ascertained the accuracy of proposed method and the results were validated as per ICH guidelines. This novel method can be used for the routine quality control of both drugs in combination in tablet dosage form Key words: Pravastatin, Fenofibrate, RP-HPLC, correlation coefficient, Validation

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