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ISSN 2063-5346
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ASSESSMENT OF SIMULTANEOUS METHOD DEVELOPMENT AND VALIDATION OF FUSIDIC ACID AND LULICONAZOLE VIA HPLC AND ITS PERCENTAGE RECOVERY FROM MARKETED PREPARATION

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Vivek G Pete, Dr Laxmikant N Barde
» doi: 10.53555/ecb/2023.12.5.519

Abstract

The combination of the luliconazole antifungal drug amd fusidic acid antibiotic drug combination is very rare but in pharmaceutical research it will be more helpful to reduce the dermal infection on the skin and patient will receive the simpler regimen at lower cost and take the benefit of this combinational therapy .But for the combination purity of the sample required and it is easily confirmed from the simultaneous method by using high performance liquid chromatography techniques (HPLC). In the present research work a HPLC method was developed and validated for assay of Fusidic acid and Luliconazole and its percentage recovery study in Topical pharmaceutical formulation. The chromatographic separation was achieved on reverse phase C18 , 5µm (125 X 4.6 mm) column at ambient temperature of 250C, at a flow rate 1 mL/min using Empower software of Waters HPLC . Different mobile phases were used on trial and error basis for separation of two drugs. The final mobile phase selected for analysis comprised of mixture of Methanol and water in the ratio of 85:15% (v/v/v). Both the drugs showed maximum absorbance at 246 nm which was selected as the wavelength of detection throughout the experimental work. Validation of developed method was carried out according to ICH guidelines. HPLC method was successfully developed for separation of fusidic acid and luliconazole with good resolution and after assessment of various parameters indicated low % RSD within an acceptable limit of < 2.0%. The developed HPLC method for estimation of FA and BD is rapid, reliable, precise, and reproducible.

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