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VALIDATION OF A CHROMATOGRAPHIC METHOD FOR MICONAZOLE ASSAY FROM ORAL SUSTAINED RELEASE MUCOADHESIVE TABLETS

MAGDALENA BÎRSAN^1*, ILEANA CORNELIA COJOCARU¹, MIHAELA MONICA SCUTARIU², IULIANA POPOVICI¹

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In order to detect the Miconazole nitrate in oral mucoadhesive sustained-release tablets, HLPC compendium assay method with UV detection, used in European Pharmacopoeia, has been developed and used. The working conditions of HLPC separation were set using C18 column (100 mm x 4.6 mm) and the mobile phase: 0.6% ammonium acetate in a mixture of 370 parts of acetonitrile, 290 parts of methanol and 340 parts of water. Detection was performed in UV at λ = 235 nm, where the miconazole nitrate reaches the maximum level of absorption. The method has been validated by determining the parameters: linearity in the chosen concentration field (0.10 – 0.70 mg/mL), correlation coefficient r2 = 0.9998, the precision of the method with a RSD of 0.833%, the intermediate precision of the method (RSD = 0.386%) and the accuracy of the method with a 99.95% retrieval percentage. A simple method of determining the antifungal has been validated, verifying the analytic performances of this method through the most important validation parameters. The created HPLC method of assay the miconazole nitrate is simple, easy to apply, sensitive, linear, precise and accurate.