Determination Of Fluticasone Propionate Research Articles

Development and validation of a novel UPLC-MS/MS method for the simultaneous determination of fluticasone propionate and salmeterol in human plasma

Development and validation of a novel UPLC-MS/MS method for the simultaneous determination of fluticasone propionate and salmeterol in human plasma

Validation of an HPLC Analytical Method for the Quantitative/Qualitative Determination of Fluticasone Propionate in Inhalation Particles on Several Matrices.

Fluticasone propionate is a highly potent corticosteroid used to treat asthma and allergic rhinitis. It is a very effective drug, but has the inconvenient factor of being insoluble in water. Cyclodextrins were used to improve this limitation because of their ability to form inclusion complexes with guest drug molecules as well as increase the stability and bioavailability of the drugs. A rapid and simple HPLC method was developed to detect and quantify fluticasone propionate in inhalation particles on several matrices. Liquid chromatography with a UV detector at a wavelength of 236 nm, using a C18 column, was employed in this study. Isocratic elution was employed using a mixture of acetonitrile and water (60:40, v/v). The analytical method validation was performed in accordance with ICH guidelines, which included selectivity, range, linearity, accuracy, detection limit, quantitation limit, precision, robustness, and stability of solutions. This method showed to be selective and specific. Acceptable assay precision and accuracy (100 ± 5.0%) were obtained at 50– 150% of the analytical concentration of fluticasone propionate at the target concentration of 0.060 mg/mL, and good linearity (0.9958) was achieved over a range of 0.03 to 0.09 mg/mL for fluticasone propionate. The proposed HPLC method proved to be reliable. The validation and application of this method can be adopted for determining the fluticasone propionate in: assays, impingers and impactors, diffusion cells, dissolutions, and other tests. In addition, this method can be adapted and used in the pharmaceutical industry for routine analysis.

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).

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).

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

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.