International Journal of Pharmaceutical Chemistry and Analysis

Method Development and Validation of RP HPLC Method for Assay and related Substances of Luliconazole in Topical Dosage form

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Article Type : Original Article

Author Details: Aditi Malasiya, Anju Goyal

Volume : 4

Issue : 2

Online ISSN : 2394-2797

Print ISSN : 2394-2789

Article First Page : 46

Article End Page : 50

Abstract

A simple, specific, accurate, precise , rapid, robust and selective stability indicating reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for assay and related substances and validated for quantification of antifungal drug with its excipients in its topical dosage form. Forced degradation study is done to determine stability of the product. The mobile phase has been used for separation consisting of ammonium acetate buffer: ACN (60:40). Column used was inertsil ODS 3V (4.6*150 mm, 5µm) with flow rate of 1.0 ml/min. Detection wavelength for luliconazole was 294 nm and for methyl paraben was 254nm. The method has been linear for both compounds at 50-150% range with r² 0.998 and 0.999 respectively. Luliconazole and methyl paraben has showed 98-102% recovery. The method have been robust under various variation with flow rate, detection wavelength and column oven temperature. The drug was exposed to stress conditions. Method resolves all degraded product as compared to luliconazole. Developed method can be used routinely for estimation of drug luliconzole with its excipient methyl paraben in dosage form and stability sample.

Keywords: Luliconazole, Methyl paraben, RP-HPLC, Stability, Antifungal, Forced degradation

Doi No:-10.18231