DEVELOPMENT AND VALIDATION OF A CHROMATOGRAPHIC ASSAY METHOD FOR THE DETERMINATION OF LULICONAZOLE IN CREAMS

A simple and rapid reverse-phase high-performance liquid chromatographic technique was developed and validated for the determination of Luliconazole in the presence of its excipients. Chromatographic elution was performed on a binary gradient HPLC equipped with PDA detector using a Luna-5 mu C8(2) 100 angstrom column (250 x 4.6 mm, 5 mu m) with orthophosphoric acid (0.1%) and methanol (20:80% w/v) as mobile phase at a flow rate of 1.2 mL/min. The method follows Beer-Lambert's law over a concentration range 0.1-200 mu g/mL (y = 53981x + 25076, R-2 = 0.999). The LOD and LOQ were found to be 0.068 mu g/mL and 0.206 mu g/mL indicating the sensitivity of the method with the required precision and accuracy. The method proved to be specific as there was no interference from the commonly used excipients in a formulation like methylparaben and also in the presence of degradants when exposed to a variety of stress conditions (acidic, alkaline, oxidation, thermal, hydrolytic and photolytic degradations). It was observed that Luliconazole was more sensitive towards alkaline conditions, and hence the proposed method, validated as per ICH guidelines proved to be stability-indicating and can be successfully applied for the determination of Luliconazole in creams.