Validation of a Stability Indicating Reversed Phase LC Method for the Determination of Fluticasone Propionate in Pharmaceutical Formulations

Abstract

A reversed phase liquid chromatography (RP-LC) method was validated for the determination of fluticasone propionate (FP) in nasal sprays. The LC method was carried out on a Shim-pack CLC-ODS column (150 mm × 4.6 mm I.D.), maintained at 35°C. The mobile phase consisted of acetonitrile/methanol/phosphate buffer (0.01 M, pH 4.0) (35:35:30, v/v/v), run at a flow rate of 1.0 mL/min and using photodiode array (PDA) detection at 240 nm. The chromatographic separation was obtained with retention time of 6.1 min, and was linear in the range of 0.05–150 µg/mL (r 2 = 0.9999). The specificity and stability indicating capability of the method were proven through degradation studies, which also showed that there was no interference of the excipients. The accuracy was 99.36% with bias lower than 1.12%. The limits of detection and quantitation were 0.03 and 0.05 µg/mL, respectively. Moreover, method validation demonstrated acceptable results for precision and robustness. The proposed method was applied for the analysis of the nasal sprays and cream pharmaceutical formulations, contributing to improve the quality control and to assure the therapeutic efficacy.