Assessment of Fusidic acid (FA) and Beclomethasone Dipropionate (BD) In Semi-solid Dosage Form Using Validated High-Performance Liquid Chromatography Method

Abstract

Objective: To develop a validated analytical method for simultaneous estimation of Fusidic acid and Beclomethasone dipropionate in
pharmaceutical combined dosage form by HPLC. Method: A HPLC method was developed and validated for assay of Fusidic acid (FA)
and Beclomethasone dipropionate (BD) in Topical pharmaceutical formulation. The chromatographic separation was achieved on Kromasil
C18, 5µm (125 X 4.6 mm) column at ambient temperature of 250C, at a flow rate 2.5 mL/min using LC-2010 CHT Liquid Chromatography,
Shimadzu HPLC system. 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, Ortho-Phosphoric acid and Acetonitrile in the ratio of 10:45:45% (v/v/v). Both the
drugs showed maximum absorbance at 220 nm which was selected as the wavelength of detection throughout the experimental work.
Validation of developed method was carried out according to ICH guidelines. Result: HPLC method was successfully developed for
separation of FA and BD with good resolution. Method validation after assessment of various parameters indicated low % RSD within an
acceptable limit of < 2.0%. Conclusion: The developed HPLC method for estimation of FA and BD is rapid, reliable, precise, and
reproducible.