Highly sensitive liquid chromatography-mass spectrometry method for the quantitative analysis of mometasone furoate in human plasma: Method validation and application to clinical pharmacokinetic studies.
LC‐MS/MS
asthma
mometasone furoate
pharmacokinetic
validation and fixed‐dose combination
Journal
Biomedical chromatography : BMC
ISSN: 1099-0801
Titre abrégé: Biomed Chromatogr
Pays: England
ID NLM: 8610241
Informations de publication
Date de publication:
10 Apr 2024
10 Apr 2024
Historique:
revised:
05
03
2024
received:
20
12
2023
accepted:
12
03
2024
medline:
11
4
2024
pubmed:
11
4
2024
entrez:
10
4
2024
Statut:
aheadofprint
Résumé
We report the development and the validation of a sensitive liquid chromatography-mass spectrometry (LC-MS/MS) method for mometasone furoate (MF) analysis in human plasma. Plasma samples were processed through liquid-liquid extraction and analyzed using LC-MS/MS operating in positive mode using multiple reaction monitoring of transitions m/z 520.9 → 355.0 and m/z 525.8 → 355.0 for MF and the internal standard (IS), respectively. Separation was achieved at 1.0 mL/min on a C
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e5871Informations de copyright
© 2024 John Wiley & Sons Ltd.
Références
Barnes, P. J. (2002). Scientific rationale for inhaled combination therapy with long‐acting β2‐agonists and corticosteroids. In. European Respiratory Journal, 19(1), 182–191. https://doi.org/10.1183/09031936.02.00283202
Beasley, R., Harper, J., Bird, G., Maijers, I., Weatherall, M., & Pavord, I. D. (2019). Inhaled corticosteroid therapy in adult asthma time for a new therapeutic dose terminology. In. American Journal of Respiratory and Critical Care Medicine, 199(12), 1471–1477. https://doi.org/10.1164/rccm.201810-1868CI
Beeh, K. M., Kirsten, A. M., Tanase, A. M., Richard, A., Cao, W., Hederer, B., Beier, J., Kornmann, O., & van Zyl‐Smit, R. N. (2018). Indacaterol acetate/mometasone furoate provides sustained improvements in lung function compared with salmeterol xinafoate/fluticasone propionate in patients with moderate‐to‐very‐severe COPD: Results from a phase ii randomized, double‐blind 12‐week study. International Journal of COPD, 13, 3923–3936. https://doi.org/10.2147/COPD.S179293
Chuchalin, A. G., Tsoi, A. N., Richter, K., Krug, N., Dahl, R., Luursema, P. B., Cameron, R., Bao, W., Higgins, M., Woessner, R., & van As, A. (2007). Safety and tolerability of indacaterol in asthma: A randomized, placebo‐controlled 28‐day study. Respiratory Medicine, 101(10), 2065–2075. https://doi.org/10.1016/j.rmed.2007.06.002
EMA—European Medicines Agency. (2015). Guideline on bioanalytical method validation. https://www.ema.europa.eu/en/bioanalytical-method-validation-scientific-guideline
Food and Drug Administration. (2018). Guidance for industry: Bioanalytical method validation, 2018. Available at: https://www.fda.gov/downloads/drugs/guidanc
Inoue, S., Vaidya, S., Tillmann, H. C., Sakita, Y., Machineni, S., Heudi, O., & Furihata, K. (2021). Pharmacokinetics of indacaterol, glycopyrronium and mometasone furoate administered as an inhaled fixed‐dose combination in Japanese and Caucasian healthy subjects. BMC Pulmonary Medicine, 21(1), 18. https://doi.org/10.1186/s12890-020-01382-6
Karpel, J. P., Busse, W. W., Noonan, M. J., Monahan, M. E., Lutsky, B., & Staudinger, H. (2005). Effects of mometasone furoate given once daily in the evening on lung function symptom control in persistent asthma. Annals of Pharmacotherapy, 39(12), 1977–1983. https://doi.org/10.1345/aph.1G410
Milgrom, H. (2010). Mometasone furoate in children with mild to moderate persistent asthma: A review of the evidence. Pediatric Drugs, 12(4), 213–221. https://doi.org/10.2165/11316220-000000000-00000
Nayak, A. S., Banov, C., Corren, J., Feinstein, B. K., Floreani, A., Friedman, B. F., Goldsobel, A., Gottschlich, G. M., Hannaway, P. J., Lampl, K. L., Lapidus, R. J., Lawrence, M., Lumry, W., Munk, Z., Pearlman, D., Scardella, A. T., Schenkel, E. J., Segal, A. T., Segall, N., & Harrison, J. E. (2000). Once‐daily mometasone furoate dry powder inhaler in the treatment of patients with persistent asthma. Annals of Allergy, Asthma & Immunology, 84(4), 417–424. https://doi.org/10.1016/S1081-1206(10)62275-2
Pavord, I. D., Beasley, R., Agusti, A., Anderson, G. P., Bel, E., Brusselle, G., Cullinan, P., Custovic, A., Ducharme, F. M., Fahy, J. V., Frey, U., Gibson, P., Heaney, L. G., Holt, P. G., Humbert, M., Lloyd, C. M., Marks, G., Martinez, F. D., Sly, P. D., … Bush, A. (2018). After asthma: Redefining airways diseases. The Lancet, 391(10118), 350–400. https://doi.org/10.1016/S0140-6736(17)30879-6
Sahasranaman, S., Tang, Y., Biniasz, D., & Hochhaus, G. (2005). A sensitive liquid chromatography‐tandem mass spectrometry method for the quantification of mometasone furoate in human plasma. Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, 819(1), 175–179. https://doi.org/10.1016/j.jchromb.2005.01.018
Stoloff, S. W., Stempel, M. A., Meyer, J., Stanford, R. H., & Carranza Rosenzweig, J. R. (2004). Improved refill persistence with fluticasone propionate and salmeterol in a single inhaler compared with other controller therapies. Journal of Allergy and Clinical Immunology, 113(2), 245–251. https://doi.org/10.1016/j.jaci.2003.10.011
Tayab, Z. R., Fardon, T. C., Lee, D. K. C., Haggart, K., McFarlane, L. C., Lipworth, B. J., & Hochhaus, G. (2007). Pharmacokinetic/pharmacodynamic evaluation of urinary cortisol suppression after inhalation of fluticasone propionate and mometasone furoate. British Journal of Clinical Pharmacology, 64(5), 698–705. https://doi.org/10.1111/j.1365-2125.2007.02919.x
To, T., Stanojevic, S., Moores, G., Gershon, A. S., Bateman, E. D., Cruz, A. A., & Boulet, L. P. (2012). Global asthma prevalence in adults: Findings from the cross‐sectional world health survey. BMC Public Health, 12(1), 204. https://doi.org/10.1186/1471-2458-12-204
Vaidya, S. S., Khindri, S., Calder, N., Machineni, S., Hara, H., Majumdar, T., Febbraro, S., Fuhr, R., & Woessner, R. (2016). Pharmacokinetics of indacaterol and mometasone furoate delivered alone or in a free or fixed dose combination in healthy subjects. Pulmonary Pharmacology & Therapeutics, 37, 30–36. https://doi.org/10.1016/j.pupt.2016.01.004
Wenzel, S. E., Jayawardena, S., Graham, N. M. H., Pirozzi, G., & Teper, A. (2016). Severe asthma and asthma‐chronic obstructive pulmonary disease syndrome – Authors' reply. The Lancet, 388(10061), 2742. https://doi.org/10.1016/S0140-6736(16)31720-2
Zachary, C. Y., Scott, T. A., Foggs, M., & Meadows, J. A. (2020). Asthma: An illustration of health care disparities. Annals of Allergy, Asthma & Immunology, 124(2), 148–149. https://doi.org/10.1016/j.anai.2019.11.011