HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF UBIDECARENONE AND CLOMIFENE CITRATE IN BULK AND TABLET DOSAGE FORMS

A validated reverse phase HPLC method has been developed for the simultaneous estimation of Ubidecarenone and Clomifene Citrate in Pharmaceutical dosage forms. The chromatographic separation was carried out on Phenomenex C8 (250 X 4.6 mm, 5 µm) column and Methanol: Ethanol: Hexane in the ratio of 80:10:10% v/v was used as mobile phase at the flow rate of 1.5 ml/min with PDA detection at 275 nm. The retention time of Ubidecarenone and Clomifene Citrate were found to be 2.37 min and 9.72 min respectively. Linearity of both drugs were found to be in the concentration range of 15-45 µg/ml for Ubidecarenone and 12.5- 37.5 µg/ml for Clomifene Citrate. The developed HPLC method was validated by determining its sensitivity, selectivity, linearity, accuracy and precision. The accuracy of the method was assessed by percentage recovery studies at three different levels at 50%, 100% and 150% of its working concentration. The percentage recovery of both drugs in the developed method was found to be in the ranges of from 99.1% 101.1%, that indicates the good accuracy of the method. This developed method can be used for the routine analysis for the estimation of Ubidecarenone and Clomifene Citrate in bulk and Pharmaceutical formulations.