HPLC method for simultaneous determination of salmeterol xinafoate and fluticasone propionate for the quality control of dry powder inhalation products

• Autorzy: Pączkowska E. , Smukowska D. , Tratkiewicz E. , Białasiewicz P.
• Języki publikacji: EN

Abstrakty

EN

A simple and accurate reversed phase high-performance liquid chromatography (HPLC) method has been developed for the estimation of uniformity of dosage units, and delivered dose uniformity tests of fluticasone propionate and salmeterol xinafoate in samples obtained during the fine particle mass determination, using C8 Luna (2) 100A 100 × 4.6 mm, 5 micrometer particle size in gradient mode, with mobile phase comprising of buffer solution: 0.6% trifluoroacetic acid solution in water-tetrahydrofurane (8:2 v/v) and acetonitrile-methanol (1:1 v/v) in the ratio of 60:40 v/v. The flow rate was 1.5 mL min ^-1, and the detection was monitored by ultraviolet (UV) detector at 239 nm and 250 nm. Linearity was observed in the concentration range of 0.025–4.8 μg Ml ^-1 for salmeterol xinafoate and 0.04–32.5 μg Ml ^-1 for fluticasone propionate (R2 > 0.999). The recovery in the range from 98.2% to 102.7% and relative standard deviation (RSD) ≤ 2.2% demonstrated accuracy and high precision of the method. The quantification limit at an injection volume of 40 μL was 0.04 μg Ml ^-1 for fluticasone propionate and 0.025 μg Ml ^-1 for salmeterol xinafoate. The developed and validated method can be successfully applied for simultaneous quality control of dry powder inhalation products containing salmeterol xinafoate and fluticasone propionate in pharmaceutical industry.

Słowa kluczowe

EN

HPLC; Andersen type cascade impactor; dry powder inhalers; fluticasone propionate; salmeterol xinafoate; quality control

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2015
• Tom: Vol. 27, no. 2
• Strony: 309--320
• Opis fizyczny: Bibliogr. 13 poz., rys., tab.

Twórcy

autor

Pączkowska E.

• Celon Pharma Ogrodowa 2a Kielpin, Lomianki 05-092 Poland

autor

Smukowska D.

• Celon Pharma Ogrodowa 2a Kielpin, Lomianki 05-092 Poland

autor

Tratkiewicz E.

• Celon Pharma Ogrodowa 2a Kielpin, Lomianki 05-092 Poland

autor

Białasiewicz P.

• Medical University of Lodz Department of Sleep Medicine and Metabolic Disorders Mazowiecka 6/8 92-215 Lodz Poland

Bibliografia

• [1] European Pharmacopoeia, EDQM, 2011. http://www.edqm.eu
• [2] Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency, London, 2009. Guideline on the Requirements for Clinical Documentation for Orally Inhaled Products (OIP) Including the Requirements for Demonstration of Therapeutic Equivalence between Two Inhaled Products for Use in the Treatment of Asthma and Chronic Obstructive Pulmonary Disease (COPD) in Adults and for Use in the Treatment of Asthma In Children And Adolescents
• [3] Y. Michael, B.Z. Chowdhry, I.C. Ashurst, M.J. Snowden, C. Davies-Cutting, and S. Gray, Int. J. Pharm., 200 , 279–288 (2000)
• [4] D. Murnane, G.P. Martin, and C. Marriott, J. Pharm. Biomed. Anal., 40, 1149–1154 (2006)
• [5] M. Taki, C. Marriott, X.M. Zeng, and G.P. Martin, The aerodynamic deposition of drugs from combination DPI formulations: The influence of particle size and drug– drug interactions. Drug Delivery to the Lungs 19, The Aerosol Society, Edinburgh, 2008
• [6] M. Taki, C. Marriott, X.M. Zeng, and G.P, Int. J. Pharm., 388, 40–51 (2010)
• [7] A. Samir, H. Salem, and M. Abdelkawy, Anal. Acta., 3, 8 (2012) (http://dx.doi.org/10.4172/2153-2435.1000180)
• [8] ICH Q2(R1) Harmonised Tripartite Guideline. Validation of Analytical Procedures: Text and Methodology, 2005. http://www.ich.org
• [9] A. Samir, H. Salem, and M. Abdelkawy, Bull. Fac. Pharm. (Cairo Univ.), 50, 121–126 (2012)
• [10] M.S. Kondawar, R.R. Shah, J.J. Waghmare, M.K. Malusare, and N.D. Shah, Inter. J. Pharm. Tech. Res., 3, 1801 1806 (2011)
• [11] L. Kasaye, A. Hymete, and I.M. Abdel-Maaboud, Saudi Pharm. J., 18, 153–159 (2010)
• [12] L. Silvestro, S.R. Savu, S.N. Savu, A. Tudoroniu, and I. Tarcomnicu, Biomed. Chromatogr., 26 , 627–635 (2012)
• [13] S.J. Carter and V. Čapka, J. Chomatogr. B, 876, 163–169 (2008)