Abstract

DEVELOPMENT AND VALIDATION OF UV- SPECTROPHOTOMETRIC AND RP-HPLC METHODS FOR ESTIMATION OF LULICONAZOLE IN BULK AND GEL FORMULATION

Puja S. Patel*, Dr. S. P. Pawar and V. H. Jain

ABSTRACT

Analytical chemistry deals with quantitative analysis of composition of substances and complex materials in various matrices by measuring a physical or chemical property of a distinctive constituent of the components of interest. Method validation is the process used to confirm that the analytical procedure employed for a specific test is suitable for its intended use. The parameters like accuracy, precision, linearity, LOD and LOQ, repeatability were studied according to ICH guidelines. The UV- spectroscopic determination was done at an absorption maximum of 284 nm. The linearity of luliconazole was found tobe in the range of 2-10μg/ml with correlation coefficient 0.9979. the % lable claim was found tobe 96.84%. the % RSD for ruggedness was 1.56. the values for LOD and LOQ were 0.0195 and 0.0590 respectively. The RP-HPLC method was applied in which luliconazole was quantified in dosage form. The HEWLETT PACKARD series 1100 instrument having diode array detector was used having autochro-3000 software. ACN:water with ratio of 85:15 were used with the help of 0.1% OPA. The flow rate was 0.7ml having ambient temperature with sample size of 20μl.the method was found tobe simple, precise, sensitive and specific.

Keywords: UV-specrophotometric, RP-HPLC, luliconazole, validation, method development.