VALIDATION OF A CHROMATOGRAPHIC
METHOD FOR MICONAZOLE ASSAY FROM
ORAL SUSTAINED RELEASE MUCOADHESIVE
TABLETS
MAGDALENA BÎRSAN1*, ILEANA CORNELIA COJOCARU1,
MIHAELA MONICA SCUTARIU2, IULIANA POPOVICIˡ
ˡ Faculty of Pharmacy, “Gr. T. Popa” University of Medicine and
Pharmacy Iasi, 16, University Street, 700115, Iași, România
2 Faculty of Dental Medicine, "Gr. T. Popa" University of Medicine and
Pharmacy Iasi, 16, University Street, 700115, Iasi, Romania
* corresponding author: magdateodor@yahoo.com
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Abstract:

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...

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