A RAPID GAS CHROMATOGRAPHY- MASS SPECTROSCOPY METHOD FOR SIMULTANEOUS QUANTIFICATION OF ORNIDAZOLE AND MICONAZOLEFROM CREAM FORMULATIONS: DEVELOPMENT, VALIDATION AND APPLICATIONAbstract
Combination drug formulations are better in terms of effectiveness and hence are used many times for treatment of diseases. The physico-chemical properties of the different API used in a formulation have a significant impact in the development of a single method for the analysis of such drugs. In the current research a rapid analytical method employing GC with Mass Spectroscopy detection has been developed and validated for simultaneous quantification of the active ingredients Ornidazole and Miconazole from the cream formulation. The analytes were extracted from cream base and filtered. A 95% dimethyl polysiloxane column with 5% phenyl polysiloxaneis used for the separation of the analytes. The method involves simple temperature gradient and MS detection. Validation of the method showed response was a linear function of concentration in the range 50-150 µg/mL for both Ornidazole and Miconazole. The method was suitably validated and was found to be precise and robust, with recoveries for both the analytes being consistent and complete. The method has been successfully applied for the analysis of samples from marketed cream formulations.