Abstract
DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR FENTICONAZOLE NITRATE IN CAPSULE DOSAGE FORM

Bansi H. Rathod*, Geeta V. Chaudhari, Priyanka Shah and Suleman S. Khoja

ABSTRACT

A reversed-phase liquid chromatographic method has been developed and validated for estimation of Fenticonazole Nitrate in capsule Dosage Form. RP-HPLC method, Column used was 150 x 4.6mm C18, Hypersil BDS with mobile phase containing 10mM phosphate buffer pH 4.5 : Acetonitrile (70%:30%v/v) . The flow rate (1.0 ml/min) and wavelength (255 nm). The retention time was found to Fenticonazole Nitrate was found to be 5.469 ± 0.01 min. Correlation co-efficient for Fenticonazole Nitrate was found to be 0.999. Assay result of marketed formulation was found to be in 99.7 % for Fenticonazole Nitrate. The proposed method was validated with respect to linearity, accuracy, precision and robustness. Percentage recovery for Fenticonazole Nitrate was found to be 100.1 – 100.3%. Analysis proves that the developed method was successfully applied for the analysis of pharmaceutical formulations and can be used for routine analysis of drugs in Quality Control laboratories.

Keywords: Fenticonazole Nitrate, HPLC, Stability indicating method, AMV, ICH, USFDA, Chromatography.


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