A New Analytical Method Development and Validation for the Determination of Fluconazole and Tinidazole in Pure Form and Marketed Pharmaceutical Dosage form by using RP HPLC

Abstract

A simple, specific, precise, and efficient method for the Simultaneous estimation of Fluconazole and Tinidazolein   pure   and   pharmaceutical   dosage   forms   by   a   Reverse   Phase-High   Performance   Liquid Chromatography  method  is  developed  and  validated.  Selected  mobile  phase  w re  in  a  combination  of Acetonitrile and Acetate buffer (pH-4.3) (35:65% v/v). Optimized column is a Develosil C18 (4.6mm×250mm) 5µm particle size and at a flow rate of 1.0mL/min  with detection wavelength  at 238nm for Fluconazole  and Tinidazole. In our study, the validation of analytical method for determination of Fluconazole and Tinidazolein pure  and  pharmaceutical   dosage forms   was   performed   in   accordance   the   parameters   including-system suitability, specificity, linearity of response, accuracy, precision (reproducibility & repeatability), robustness (change of wave length±2 nm). The method is validated according to ICH guidelines.In RP-HPLC method, the calibration graphs were linear in the concentration range of 10-30µg/ml for Fluconazole and 30-90µg/ml for Tinidazole  with  percentage  recoveries  are within  the limits.  The results  obtained  by RP-HPLC  methods  are rapid, accurate and precise. Therefore, proposed method can be used for routine analysis of Fluconazole and Tinidazolein the pure form as well as in combined pharmaceutical dosage form.