METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF CLOTRIMAZOLE, MICONAZOLE NITRATE, AND TINIDAZOLE BY REVERSED-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD IN TABLETS

Abstract

Objective: The aim of the study is to develop and validate a high-performance liquid chromatographic method for the simultaneous determination of clotrimazole, miconazole nitrate, and tinidazole tablet dosage forms. Materials and Methods: A Waters C18 column (50 mm×4.6 mm, 5 μm) with mobile phase consisting of acetonitrile, methanol, and water 55:25:20 (v/v) (pH 2.5 adjusting with 0.5% orthophosphoric acid) was used. The flow rate was 1.0 ml/min, and effluents were monitored at 210 nm. Results: The retention time of miconazole nitrate, tinidazole, and clotrimazole tablets was found to be 2.9 min, 3.5 min, and 4.7 min, respectively. The method was validated according to the ICH guidelines for specificity, limit of detection, limit of quantification, precision, accuracy, linearity, ruggedness, and robustness. Conclusion: The method shows good reproducibility and recovery with % relative standard deviation <2. Hence, the proposed method was found to be simple, specific, precise, accurate, and linear. Hence, it can be applied for routine analysis of clotrimazole, miconazole nitrate, and tinidazole in pharmaceutical combined dosage forms.