RP-HPLC method development and validation of Ciprofibrate from bulk and pharmaceutical formulation

Abstract

A rapid, highly sensitive high performance liquid chromatographic method has been developed for the determination of Ciprofibrate (CPF) in bulk drug and in tablets. CPF was eluted from a Qualisil C₈ reversed phase column at temperature (30ºC) with a mobile phase consisting of methanol and water (90:10, v/v) at a flow rate of 1 mL/min with UV detection at 232 nm. The retention time was ~ 4.6 min and each analysis took not more than 6 min. Quantitation was achieved by measurement of peak area without using any internal standard. Calibration graph was linear from 2.0 to 12 mg/mL with limits of detection (LOD) and quantification (LOQ) being 0.24 and 0.73 mg/mL, respectively. The method was validated according to the current ICH guidelines. The % recovery was found to be within the limits of the acceptance criteria with average recovery of 98.65– 100.01%. The % RSD value for intra-day and inter-day precision was found to be in the range of 0.29-1.56. The % RSD below 2.0 shows the high precision of proposed method. According to USP, system suitability tests are an integral part of chromatographic methods. They are used to verify the reproducibility of the chromatographic system.