Development and Validation of an Analytical Method for Simultaneous Estimation of Clotrimazole and its Impurity by RP-HPLC

A simple, efficient and reproducible method for the simultaneous determination of Clotrimazole and its Impurity (2-Chlorphenyl diphenyl methanol) has been developed using reversed phase high performance liquid chromatography. The separation was carried out using a mobile phase consisting of methanol: acetonitrile (95: 5% v/v). Column used was Zorbax C18 (100 × 4.6 mm internal diameter) 3.5 μm with flow rate of 1 ml/min. The detection wavelength used was 225 nm. The retention time of Clotrimazole and 2-Chlorophenyl diphenyl methanol were 2.81 and 2.14 respectively. Linearity of Clotrimazole and its Impurity are in range of 10–80 μg/mL and 2–12 μg/mL respectively. Analytical parameters were calculated and a statistical evaluation included.