Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF HYDROCORTISONE AND MICONAZOLE SIMULTANIOUS IN TOPICAL DOSAGE FORM BY RP-HPLC

A. Yadagiri Naga Manikanta*

Abstract

A simple reverse phase high perfomance liquid chromatographic method has been developed and subsequently validated for simultaneous determination of Hydrocortisone and miconazole in combined dosage form. The separation was carried out using a mobile phase consisting of methanol and mono basic potassium phosphate buffer in the ratio of 80:20 v/v. The column used was Inertsil –ODS C18 (250 × 4.6 mm, 5μ) with flow rate of1.0ml/min using PDA detection at 239nm. The described method was linear over a concentration range of 20ppm to 80ppm for the assay of Hydrocortisone and miconazole respectively. The retention times of Hydrocortisone and miconazole were found to be 3.942min and 2.869min respectively. Results of analysis were validated statistically and by recovery studies. The limit of quantification (LOQ) for Hydrocortisone and miconazole were found to be 1.69mg/ml and 1.74mg/ml respectively. Then the limit of detection (LOD) for Hydrocortisone and miconazole were found to be 0.56 mg/ml and 0.57 mg/ml respectively. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate which is useful for the routine determination of Hydrocortisone and miconazole bulk drug and in its pharmaceutical dosage form.

Keywords: Hydrocortisone, miconazole, methanol.