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.
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).
Sangoi
Maximiliano da Silva
Mda S
Faculty of Pharmacy, Federal University of Rio Grande do Sul, 90610-000 Porto Alegre-RS, Brazil. maxsilvasangoi@yahoo.com.br
Wrasse
Micheli
M
D'Avila
Felipe Bianchini
FB
Bernardi
Raquel Martini
RM
de Oliveira
Paulo Renato
PR
Dalmora
Sérgio Luiz
SL
Bueno Rolim
Clarice Madalena
CM
D000281:Administration, Intranasal; D000730:Androstadienes / Q000032:analysis*; D018926:Anti-Allergic Agents / Q000032:analysis*; D000893:Anti-Inflammatory Agents / Q000032:analysis; D002853:Chromatography, Liquid / Q000379:methods* / Q000592:standards; D019075:Electrophoresis, Capillary / Q000379:methods* / Q000592:standards; D000068298:Fluticasone; D006801:Humans; D011282:Pregnenediones / Q000032:analysis; D012015:Reference Standards; D053719:Tandem Mass Spectrometry / Q000379:methods* / Q000592:standards
D000730:Androstadienes; D018926:Anti-Allergic Agents; D000893:Anti-Inflammatory Agents; D011282:Pregnenediones; D000068298:Fluticasone; C021988:deflazacort