ISSN (Online) : 2277-4572

Development and Validation of RP-HPLC Method for Simultaneous estimation of Metronidazole and Clotrimazole in Pessaries Dosage Form


Author(s): Parul Bisht, Shivanand Patil and Rumi Koju*

Simple reversed phase high performance liquid chromatography may be used to measure Metronidazole and Clotrimazole simultaneously. The system with Buffer (0.1M of monobasic potassium phosphate pH 2.4) (70): Acetonitrile (30) with 2.0 ml / min flow rate was discovered to be best for separation of compounds. The optimum detection wavelength was 210 nm. Metronidazole and clotrimazole were shown to have retention periods of 1.13 minutes and 10.8 minutes, respectively. The method was found to be linear with R2 0.9993 and 0.9958 for metronidazole and clotrimazole respectively. The technique was discovered to be precise and accurate. A system suitability test was also carried out to confirm the chromatographic system's reproducibility. In specificity study, the peaks of metronidazole and clotrimazole were detected separately from blank values demonstrating that the method is specific for the active ingredient.

The stability studies showed that the solutions of metronidazole and clotrimazole was stable for up to 24 hours for both the sample stored at room temperature and stored at 2?C to 8?C. By changing the chromatographic parameters, such as the ratio of solvents in the mobile phase composition, flow rate, change in ratio of solvents in column length and other factors, the robustness of the approach was assessed. The influence of changes of chromatographic parameters on peak parameters was found to significant on theoretical plate and tailing factor but it showed insignificant effect on retention time. Hence, the method was robust except for tailing factor and theoretical plates which demonstrate that the slight changes in chromatographic condition may vary tailing factor and theoretical plates of metronidazole and clotrimazole