Optimized Chromatographic Method for Cleaning Validation and Residue Determination of Fenofibrate in Pharmaceutical Equipment

Cleaning validation is an essential step to keep drug products both safe and effective by avoiding crosscontamination.In this paper, an optimized chromatographic technique for identifying equipment process used in the preparation of Fenofibrate formulations has been reported.This paper set out to maximize chromatographic conditions for the residues analysis of Fenofibrate.Three chromatographic techniques were compared, and the optimized conditions were finalized based on precision, accuracy, linearity, and robustness.The optimized parameters were the use of a C18 column, with a flow rate of 1.2 ml/min., oven temperature of 35C, injection volume of 20 l, and detection wavelength of 286 nm.Mobile phase was Buffer-A (H2O with 1.0 ml TFA) and Buffer-B (MeOH with 1.0 ml TFA) in the ratio of 20:80.The approach was validated for limit of quantitation (LOQ), linearity, precision, accuracy, and robustness.LOQ was found to be 0.08 g/ml for the quantification of Fenofibrate residues.Linearity was established for a range of concentrations between LOQ and 200% of the critical limit, while precision and accuracy experiments established method reproducibility.Robustness testing also established the stability of the method under different chromatographic conditions