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
Keyword :
Pravastatin, Fenofibrate, RP-HPLC, correlation coefficient, Validation