Abstract

DEVELOPMENT AND VALIDATION OF THE UV-SPECTROPHOTOMETRIC AND RP-HPLC METHOD FOR SIMULTENIOUS ESTIMATION OF ITRACONAZOLE AND TERBINAFINE HYDROCHLORIDE IN BULK AND IN FORMULATION

Prachi R. Chaudhari*, Dr. J. K. Patil, V. H. Jain and Dr. S. P. Pawar

ABSTRACT

The main objective was develop and validate the UV-Spectrophotometric and RP-HPLC method for the estimation ofitraconazole and terbinafine hydrochloride in bulk and pharmaceutical formulations as per ICH guidelines. An UV-Spectrophotometric method for the quantitative determination of itraconazole and terbinafine hydrochloride a highly potent antimycotic in tablet was developed in present work. The parameters linearity, precision, accuracy, limit of detection, limit of quantitationwere studied according to ICH Guideline UV Spectroscopic determination was carried out at an absorption maximum of 247 nm using methanol as solvent. In the UV spectroscopic method linearity over the concentration range of itraconazole was found to be 1-5μgm/ml with a correlation coefficient 0.9978. And for terbinafine hydrochloride was found to 2.5-10μgm/ml with a correlation coefficient 0.9986. result of the analysis were validated statisticaly and by recoverybstudies. The proposed method is simple, rapid, precise and accurate and can be used for the reliable quantitation of itraconazole and terbinafine hydrochloride in pharmaceutical formulation. A RP-HPLC method has been developed and validated to determine itraconazole and terbinafine hydrochloride in tablet dosage form. The chromatography was performed on c18 column and a mobile phase consisting of methanol and 0.1% OPA in water(65:35) eluents

Keywords: where monitored by uv photo diode array detector at wawelength of 230 nm. The flow rate was 1ml. The method was validated for linearity, precision, specificity, accuracy, Limit of detection, limit of quantification and robustness.