Abstract
Fusidic acid is an antibiotic steroid indicated for the treatment of infections caused by the genus Staphylococcus, including methicillin resistant Staphylococcus aureus strains, and other Gram-positive bacteria. In the present study, a stability-indicating reversed-phase liquid chromatography (RP-LC) method was developed and validated for the determination of fusidic acid in dermatological cream as an alternative to existing methods. Analyses were performed using a C18 column and guard column at room temperature, eluting with an isocratic mobile phase of acetonitrile and water (72:28, v/v), adjusted to pH 3.5 with acetic acid, pumped at a flow rate of 1.0 mL min-1, detection at 210 nm and 20 µL of injection volume. The forced degradation study was conducted under acidic, alkaline, neutral, photolytic, and oxidative stress conditions. The method was validated according to ICH and FDA guidelines; it was linear, precise, accurate, selective, and robust over concentrations of 5-95 µg mL-1, with detection and quantification limits of 0.43 and 1.31 μg mL-1, respectively. Therefore, we conclude that this method is suitable for quantifying fusidic acid in pharmaceutical dermatological creams and determining its stability, representing a more economical and practical alternative for routine analysis in quality control.
Highlights
Fusidic acid (FA), an antibiotic steroid (Godtfredsen, Vangedal, 1962) (Figure 1), has been used widely in the topical and systemic treatment of infections caused by Gram-positive microorganisms since 1962 (Jones et al, 2011; Spelman, 1999)
These include strains resistant to penicillin and other antibiotics (França, 2010), providing an alternative for the treatment of diseases caused by methicillin resistant Staphylococcus aureus strains, abbreviated as MRSA (Anderson, 1980; Falagas, Kopterides, 2007)
Adequate precision was observed for the values of retention time and chromatographic peak areas of FA, which had an relative standard deviation (RSD) below 2%, which is recommended for conformance testing (FDA, 1994)
Summary
Fusidic acid (FA), an antibiotic steroid (Godtfredsen, Vangedal, 1962) (Figure 1), has been used widely in the topical and systemic treatment of infections caused by Gram-positive microorganisms since 1962 (Jones et al, 2011; Spelman, 1999). These include strains resistant to penicillin and other antibiotics (França, 2010), providing an alternative for the treatment of diseases caused by methicillin resistant Staphylococcus aureus strains, abbreviated as MRSA (Anderson, 1980; Falagas, Kopterides, 2007). Salgado occupies a prominent place among modern methods of analysis, due to its ease in effecting the separation, identification, and quantification of chemical substances and their degradation products (Snyder, Kirkland, Dolan, 2010)
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