HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF AMPHIPATHIC DERIVATIVEFENOFIBRATE FROM RAT PLASMA

A rapid, sensitive, accurate HPLC analytical method development was determination of fenofibrate in rat serum. Nevirapine was used as an internal standard (IS). Absorbance UV detector at wavelength of detection was as set at 295nm. Separation was carried out on inertial C18 column (4.6x250mmx5?m) using 60:40 v/v ammonium acetate buffer, Acetonitrile as mobile phase at a flow rate of 1.0 ml/min. Analytical run time was less than 10 min. The % mean recovery for Fenofibrate in LQC, MQC and HQC was 62.7%, 64.2 % and 65.3% for 0.3 to 20.0?g/mL concentrations. The intraday and interday precision and Accuracy of the method was found to be 0.09 to 5.03% and 100.00 to 100.20% respectively. The limit of Quantification was found to be 0.3?g/ml at such concentration the inter day precision was found to be 0.07 to 0.29. The method was validated with excellent sensitivity, accuracy, precision and recovery. The assay has been applied to pharmacokinetic studies. Key words: HPLC, Fenofibrate, Nevirapine