Determination of fluticasone propionate in nasal sprays by a validated stability-indicating MEKC method.
A micellar electrokinetic chromatography method (MEKC) is developed and validated for the analysis of fluticasone propionate (FP) in nasal sprays. The MEKC method is performed on a fused-silica capillary (50 mum i.d.; effective length, 40 cm). The background electrolyte consists of 25 mM borate and 25 mM anionic detergent SDS solution at pH 9. The capillary temperature is maintained at 35 degrees C, and the applied voltage is 20 kV. The injection is performed using the hydrodynamic mode at 50 mbar for 6 s with detection at 238 nm. The method is linear in the range of 2-80 mug/mL (r(2) = 0.9956). The specificity and stability-indicating capability are proven through forced degradation studies inclusive by mass spectrometry, which also shows that there is no interference of the excipients. The limit of detection and limit of quantitation are 0.56 and 2 mug/mL, respectively. Moreover, method validation demonstrates acceptable results for accuracy, precision, and robustness. The proposed method was successfully applied for the quantitative analysis of FP nasal sprays, and the results were compared to a validated reversed-phase liquid chromatographic method, showing non-significant difference (P > 0.05).
Sangoi
Maximiliano da Silva
Mda S
Department of Industrial Pharmacy, Federal University of Santa Maria, 97105-900 Santa Maria-RS, Brazil.
da Silva
Lucélia Magalhães
LM
D'Avila
Felipe Bianchini
FB
Dalmora
Sérgio Luiz
SL
D000730:Androstadienes / Q000032:analysis* / Q000737:chemistry; D001881:Borates; D020374:Chromatography, Micellar Electrokinetic Capillary / Q000379:methods*; D004355:Drug Stability; D000068298:Fluticasone; D006863:Hydrogen-Ion Concentration; D016018:Least-Squares Analysis; D059085:Nasal Sprays; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012967:Sodium Dodecyl Sulfate; D013696:Temperature
D000730:Androstadienes; D001881:Borates; D059085:Nasal Sprays; D012967:Sodium Dodecyl Sulfate; D000068298:Fluticasone