Stability-indicating RP-LC method for quantification of fusidic acid in cream

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 C 18 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 , 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. Uniterms:Fusidic acid/stability-indicating/quality control/validation. Chromatography/reversed-phase.

Formulation and Molecular Dynamics Simulations of a Fusidic Acid Nanosuspension for Simultaneously Enhancing Solubility and Antibacterial Activity

“…A shake-flask method was used to determine the solubility of FA-NS and FA in water. Excess quantities of FA and lyophilized FA-NS were added to the Milli-Q water (10 mL) and placed in a shaking incubator at a temperature of 25 °C for 24 h. The undissolved FA was removed by filtering through syringe filters (cellulose acetate membrane, 0.2 μm, GVS Filter Technology, USA), , with the FA content being determine by HPLC (Shimadzu, Japan) using a reported method . The mobile phase was composed of acetonitrile and water (70:30, v/v) that was adjusted to pH 3.5 with acetic acid.…”

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

“…[5] Although, various analytical techniques have been developed for estimation of FA and BD individually or with other components in bulk drug and pharmaceutical dosage forms, the efficient and cost-effective analytical method has not yet been determined for estimation of these drugs. [2,[6][7][8][9][10] In general, from the analytical chemistry point of view and as per the AOAC International; any analytical quantitative methods should meet the certain minimal performance criteria. [11] Now a days, submission of analytical method validation data is mandatory regulatory requirements for getting the necessary approvals.…”

Analytical method development and determination of hydrocortisone acetate and fusidic acid simultaneously in cream formulation, by reversed‐phase HPLC

“…Fusidic acid (FA) is an antibiotic, having a steroid‐like structure chemically designated as ent‐(17 Z )‐16 α ‐(acetyloxy)‐3 β ,11 β ‐dihydroxy‐4 β ,8,14‐trimethyl‐18‐nor‐5b,10 α cholesta‐17(20),24‐dien‐21‐oic acid (BP, 2019) as shown in Figure 1, with a bactericidal or bacteriostatic activity. Fusidic acid, first isolated from the fermentation process of certain strains of Fusidium coccineum in 1962 by Godtfredsen (Byrne et al, 2014), is mainly effective for the treatment of infections caused by Gram‐positive bacteria, such as Staphylococcus species including Staphylococcus aureus (Curbete & Salgado, 2016). Fusidic acid is used in pharmaceutical topical forms for the treatment of mild to severe infections of soft tissues and skin, e.g.…”