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Article

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

by
André R. Sá COUTO
,
Daniela Espinha CARDOSO
and
Helena Maria CABRAL-MARQUES
*
Research Institute for Medicines and Pharmaceutical Sciences (iMed.UL), Faculty of Pharmacy, University of Lisbon. Av. Prof. Gama Pinto, 1649-003 Lisbon, Portugal
*
Author to whom correspondence should be addressed.
Sci. Pharm. 2014, 82(4), 787-798; https://doi.org/10.3797/scipharm.1404-11
Submission received: 22 April 2014 / Accepted: 16 June 2014 / Published: 16 June 2014

Abstract

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.
Keywords: HPLC; Fluticasone propionate; Gamma-cyclodextrin; Analytical validation; Inhalation HPLC; Fluticasone propionate; Gamma-cyclodextrin; Analytical validation; Inhalation

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MDPI and ACS Style

COUTO, A.R.S.; CARDOSO, D.E.; CABRAL-MARQUES, H.M. Validation of an HPLC Analytical Method for the Quantitative/Qualitative Determination of Fluticasone Propionate in Inhalation Particles on Several Matrices. Sci. Pharm. 2014, 82, 787-798. https://doi.org/10.3797/scipharm.1404-11

AMA Style

COUTO ARS, CARDOSO DE, CABRAL-MARQUES HM. Validation of an HPLC Analytical Method for the Quantitative/Qualitative Determination of Fluticasone Propionate in Inhalation Particles on Several Matrices. Scientia Pharmaceutica. 2014; 82(4):787-798. https://doi.org/10.3797/scipharm.1404-11

Chicago/Turabian Style

COUTO, André R. Sá, Daniela Espinha CARDOSO, and Helena Maria CABRAL-MARQUES. 2014. "Validation of an HPLC Analytical Method for the Quantitative/Qualitative Determination of Fluticasone Propionate in Inhalation Particles on Several Matrices" Scientia Pharmaceutica 82, no. 4: 787-798. https://doi.org/10.3797/scipharm.1404-11

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