Abstract

HPLC METHOD DEVELOPMENT AND VALIDATION OF DEFLAZACORT AND TAMSULOSIN HYDROCHLORIDE IN COMBINED DOSAGE FORM

Vijay V. Rupapara*, Dr. Zarna R. Dedania and Dr. Ronak Dedania

Abstract

The HPLC method was also developed and validated for simultaneous estimation of Deflazacort and Tamsulosin hydrochloride in combined dosage form. For the HPLC method, the linearity range lies between 37.5-112.5 μg/ml for Deflazacort and 0.5-1.5 μg/ml for Tamsulosin hydrochloride with co-relation coefficients of 0.9995 and 0.9924 respectively for both drugs. The percentage recovery was found to 99.51-99.97% for Deflazacort and 99.55-99.72% for Tamsulosin hydrochloride. LOD value was found to 2.61μg/ml and 0.132μg/ml for Deflazacort and Tamsulosin hydrochloride respectively. LOQ value was found to 7.90μg/ml and 0.40μg/ml for Deflazacort and Tamsulosin hydrochloride respectively. The assay result for Deflazacort and Tamsulosin hydrochloride was found to be 102.37 and 93.09% comparable indicating the good agreement with the label claim.

Keywords: Deflazacort, Tamsulosin hydrochloride, HPLC, Validation.