RP-HPLC Method Development and Validation for Simultaneous Estimation of Lignocaine Hydrochloride and Clotrimazole Hydrochloride in Ear Drops

A rapid and precise Reverse Phase High Performance Liquid Chromatographic method has been developed for the validated of Lignocaine and Clotrimazole, in its pure form as well as in ear drops. Chromatography was carried out on a Phenomenex C18 (4.6×250mm) 5μ column using a mixture of Methanol, Acetonitrile and potassium dihydrogen phosphate buffer (50:20:30) as the mobile phase at a flow rate of 1.2 ml/min, the detection was carried out at 220nm. The retention time of the Clotrimazole and Lignocaine was 2.266, 6.349min respectively. The method produce linear responses in the concentration range of 10-60μg/ml of Clotrimazole and 10-60μg/ml of Lignocaine. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of pharmaceutical formulations.