Determination of sodium fusidate in dosage forms by high performance liquid chromatography

Abstract

A simple HPLC procedure, suitable for the determination of sodium fusidate (SF) in dosage forms, was developed. The method involves using a UV detector (208 nm) in the presence of basic buffered media (pH 7.25) under reversed-phase conditions (Supelcosil(R) LC18(TM), 3 mu m particles). The linear regression between the concentration of SF and the peak area, y = -4.4566 + 8.9238x with a coefficient of correlation r = 0.9985, was confirmed for SF in the concentration range from 25 mu g/ml to 150 mu g/ml. The detection limit of SF was 12.5 mu g/ml. The HPLC method was applied for the determination of SF in dosage forms: Stanicid(R) coated tablets, Stanicid(R) ointment and Stanicid(R) sterile gauze dressing. The concentrations and statistical parameters of sodium fusidate for all the investigated dosage forms were satisfactory and ranged from 100.41 to 105.39% (the R. S. D. ranged from 1.51 to 2.75%).