LIQUID CHROMATOGRAPHY TANDEM MASS SPECTROMETRY DETERMINATION METHOD OF BENCYCLOQUIDIUM BROMIDE: APPLICATION TO DRUG INTERACTION STUDY IN HUMAN
DOI:
https://doi.org/10.22159/ijpps.2021v13i10.5791Keywords:
Bencycloquidium bromide, LC-MS/MS, Pharmacokinetic drug interaction, ParoxetineAbstract
Objective: This study was conducted to develop a sensitive and effective LC-MS/MS method for the determination of bencycloquidium bromide (BCQB) and its application in pharmacokinetic drug interaction study between BCQB and paroxetine.
Methods: The chromatographic separation was performed on Hedera ODS-2 C18 column with a mobile phase consisted of acetonitrile-10 mmol/l ammonium acetate containing 0.2% acetic acid (33:67, v/v) at 550 μl/min, and the plasma samples were processed using solid-phase extraction. The MS/MS transitions were m/z 330.2 → 142.0 for BCQB and m/z 344.2 → 156.1 for the I. S in positive ESI mode.
Results: The validated method was linear over the concentration range of 2-1200 pg/ml with the correlation coefficient r2>0.998. The intra-and inter-batch precisions of the assay were lower than 8.2% and 9.1%, respectively. The lower limit of quantification (LLOQ) was 2 pg/ml. The stability data at different storage conditions of BCQB were within±5% RE. The mean AUC0-36 of BCQB was increased by approximately 33%, after the administration of BCQB alone and upon co-administration with paroxetine during the drug interaction study.
Conclusion: The LC-MS/MS method validated in this study was robust, reproducible, accurate, precise and reliable and was successfully applied in the pharmacokinetic drug interaction studies.
Downloads
References
Cao R, Dong XW, Jiang JX, Yan XF, He JS, Deng YM, Li FF, Bao MJ, Xie YC, Chen XP, Xie QM. M(3) muscarinic receptor antagonist bencycloquidium bromide attenuates allergic airway inflammation, hyperresponsiveness and remodeling in mice. Eur J Pharmacol. 2011;655(1-3):83-90. doi: 10.1016/ j.ejphar.2011.01.024, PMID 21277298.
Jiang JX, Cao R, Deng WD, Jin F, Dong XW, Zhu Y, Chen XP, Xie YC, Bao MJ, Li FF, Xie QM. Characterization of bencycloquidium bromide, a novel muscarinic M(3) receptor antagonist in guinea pig airways. Eur J Pharmacol. 2011;655(1-3):74-82. doi: 10.1016/j.ejphar.2011.01.017, PMID 21272572.
Li J, He H, Zhou YD, Yuan P, Chen XP. Subchronic toxicity and toxicokinetics of long-term intranasal administration of bencycloquidium bromide: a 91-day study in dogs. Regul Toxicol Pharmacol. 2011;59(2):343-52. doi: 10.1016/j.yrtph.2010.11.006, PMID 21130130.
Li J, Zhou YD, Chen XP. Preliminary observation on the anti-inflammatory action and anti-pruritic action of bencycloquidium bromide. Chin J New Drugs. 2007;16:1182-4.
Li J, Zhou YD, Chen XP. Experimental study on general pharmacological actions of bencycloquidium bromide. J Chongqing Med Univ. 2007;32:506-10.
Sun L, Ding L, Wang Y, Zhou W, Yan Z, Sun W, Zhang H, Ou N, Chen X. Pharmacokinetics, safety and tolerability of bencycloquidium bromide, a novel selective muscarinic M1/M3 receptor antagonist, after single and multiple intranasal doses in healthy Chinese subjects. Drugs RD. 2012;12(1):17-28. doi: 10.2165/11599330-000000000-00000, PMID 22339483.
Agbokponto JE, Zhang L, Hu L, Feng H, Ding L. In vitro metabolism of Bencycloquidium bromide and its inhibitory effects on human P450 isoenzymes: implication of CYP2D6, CYP2C19 and CYP3A4/5. Eur J Drug Metab Pharmacokinet. 2016;41(1):69-77. doi: 10.1007/s13318-014-0237-2, PMID 25425116.
Sun L, Ding L, Yan Z, Du XL, Luo XM, Chen X. Determination of the inhibitory potency of bencycloquidium bromide on rat liver cytochrome P450 by LC-MS/MS. J China Pharm Univ. 2013;44(2):134-40.
Shankar GG, Pragney D, Ramakrishna S. Simultaneous determination of atorvastatin and olmesartan medoxomil in rat plasma by liquid chromatography-electrospray ionization tandem mass spectrometry and its application to pharmacokinetics in rats. Int J Pharm Pharm Sci. 2014;6(10):464-8.
Hu L, Agbokponto JE, Li X, Ding L, Liu B, Zhong S, Zhang X, Du Y. In vivo and in vitro evidence of the sex-dependent pharmacokinetics and disposition of G004, a potential hypoglycemic agent, in rats. Eur J Drug Metab Pharmacokinet. 2015;40(2):187-202. doi: 10.1007/s13318-014-0196-7, PMID 24696324.
Xu Q, Ding L, Liu WY, Bian XJ, Tang W. Determination of bencycloquidium bromide in rat plasma by liquid chromatography-electrospray ionization-mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2007;846(1-2):209-14. doi: 10.1016/j.jchromb.2006.09.028, PMID 17055347.
Jiang B, Ruan Z, Lou H, Dong X, Xie Q. Determination of bencycloquidium bromide in dog plasma by liquid chromatography with electrospray ionization tandem mass spectrometry. Biomed Chromatogr. 2010;24(5):490-6. doi: 10.1002/bmc.1316, PMID 19688815.
Zhou W, Ding L, Wang Y, Sun L, Huang Y, Hu L, Chen X. Solid phase extraction and liquid chromatography-electrospray ionization-mass spectrometry for the determination of bencycloquidium bromide in human plasma. J Chromatogr B Analyt Technol Biomed Life Sci. 2009;877(10):897-901. doi: 10.1016/j.jchromb.2009.02.027, PMID 19251489.
International Conference on Harmonization (ICH), Guidance for Industry: Bioanalytical Method Validation. Register, Rockville: US FDA; 2001.
Agbokponto JE, Luo Z, Liu R, Liu Z, Liang M, Ding L. Study of pharmacokinetic interaction of paroxetine and roxithromycin on bencycloquidium bromide in healthy subjects. Eur J Pharm Sci. 2015;69:37-43. doi: 10.1016/j.ejps.2014.12.019, PMID 25559065.
Published
How to Cite
Issue
Section
Copyright (c) 2021 JANVIER ENGELBERT AGBOKPONTO, LOCONON ACHILLE YEMOA, ASSOGBA GABIN ASSANHOU, RUIJUAN LIU, HABIB GANFON, LI DING
This work is licensed under a Creative Commons Attribution 4.0 International License.