Recent Development and Validation of a RP-HPLC Analytical Method for the Simultaneous Determination of Luliconazole and Clobetasol Propionate in Synthetic Mixture

Abstract

Aim: In the present research our aim to developed an analytical method to find out the drug concentration/or analysis in the mixtures of both of the drugs antifungal drug Luliconazole integrate with corticosteroid drug Clobetasol Propionate in a synthetic mixture, irrespective of their formulation.

Method: The method was validated to achieve International Conference Harmonization (ICH) requirements. Chromatographic separation was carried out by isocratic technique on a reversed-phase Inertsil C18 column (5 \(\mu\)m, 250mm x 4.6mm i.d with the mixture of Acetonitrile: Water pH adjusted with H₃PO₄ (60: 40) and UV detection at 264 nm. The compounds were eluted at a flow rate of 1.0 mL/min with an injection volume of 20\(\mu\)L.

Results: The calibration curves were linear (r² > 0.999) over the concentration range 10-200 \(\mu\)g/mLfor Luliconazole and 5-100 \(\mu\)g/mL for Clobetasol Propionate. The average retention times for Luliconazole and Clobetasol Propionate were 3.16 and 6.94 min, respectively. The % RSD   for the proposed method was found to be less than %2. The % recovery was found to between 99.22-99.48% for the developed method.

Conclusion: The developed method is simple, rapid, precise, and accurate and hence was successfully applied for the determination of Luliconazole and Clobetasol Propionate in a synthetic mixture.