Development and Validation of a Robust and Rapid UV Spectroscopic Method for Estimation of Luliconazole and Clobetasol Propionate Drug Combination

Abstract

Objective: The new combination for Luliconazole and Clobetasol Propionate was approved for the treatment of variety of skin disease. The aim of this study is development and validation of fast, steady, precise and economic derivative spectrophotometry process for evaluating the newly approved combination Luliconazole and Clobetasol Propionate.

Methodology: Here in this first derivative spectroscopic method, the absorbance of LLZ and CLP was taken at 312nm (ZCP of CLP) and 249nm (ZCP of LLZ) respectively. Establishment of linearity was in a concentration varies from 10-50 \(\mu\)g/ml for Luliconazole and 5-25\(\mu\)g/ml for Clobetasole Propionate.

Result: From the method developed above the R² value observed for LLZ and CLP is 0.9988 and 0.9961. Statistical validation of accuracy and reproducibility was done for planned procedure with the help of recovery studies. The mean % recovery of Luliconazole and Clobetasol Propionate was found to be 99.45 % and 99.43% respectively. For LLZ the Limit of detection is 0.0054 \(\mu\)g/ml and limit of quantification is 0.0164 \(\mu\)g/ml and for CLP the Limit of detection is 0.0009 \(\mu\)g/ml and limit of quantification 0.0027 \(\mu\)g/ml.

Conclusion: From research work the method development was done and shows fast, precise, exact and easily accessible laboratory procedure for routine evaluation of combination drugs.