A High-Throughput Liquid Chromatography Tandem Mass Spectrometry Method for the Comparative Determination of Fluticasone Propionate by Reversed-Phase Liquid Chromatography and Capillary Electrophoresis Methods in Pharmaceutical Nasal Sprays

Abstract

A simple, specific, rapid and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the analysis of fluticasone propionate (FP) in pharmaceutical formulations was developed and validated using deflazacort as internal standard (IS). The LC-MS/MS method was carried out on a C8 column (50 mm) with a mobile phase consisted of methanol:water (95:5, v/v)–100 mM formic acid–50 mM ammonium acetate (90:5:5, v/v/v). The mass spectrometry method was performed employing positive atmospheric pressure chemical ionization technique, operating in multiple reaction monitoring mode. The chromatographic separation was obtained within 1.5 min and it was linear in the concentration range of 10–1000 ng mL−1. Moreover, method validation demonstrates acceptable results for the specificity, accuracy, precision and robustness. The proposed method was successfully applied for the quantitative analysis of FP nasal sprays and the results were compared to validated liquid chromatography and capillary electrophoresis methods with photodiode array detectors showing non-significant difference ( P > 0.05).