Prachi Barbhaiya
Development and validation of stability indicating analytical method for simultaneous estimation of miconazole and ornidazole in their combined marketed dosage form
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A simple, precise, accurate, sensitive, specific and reliable stability indicating RP-HPLC method was developed for the simultaneous estimation of Miconazole (MIC) and Ornidazole (ORN) in pharmaceutical dosage form. The method was developed with mobile phase containing buffer (0.05M potassium dihydrogen ortho phosphate, ph3.5): Methanol in the ratio of 25:75, C18 (250 x 4.6mm, 5µm) as a stationary phase and flow rate was 1 ml/min. Detection was carried out at 236nm in UV-2000 detector. The selected chromatographic conditions were found effectively to separate Miconazole and Ornidazole at 6.58 and 3.26 min respectively. The proposed method has been validated for precision, accuracy, robustness. Thus, the statistical analysis confirms that developed methods were successfully used for analysis of formulation and thereby can be used for routine analysis of drugs in Quality Control laboratories.
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Stability studies ensuring the maintenance of product quality, safety and efficacy throughout the shelf life are considered as pre-requisite for the acceptance and approval of any ...