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Article: LC/ESI-MS method for the determination of trimetazidine in human plasma: Application to a bioequivalence study on Chinese volunteers

TitleLC/ESI-MS method for the determination of trimetazidine in human plasma: Application to a bioequivalence study on Chinese volunteers
Authors
KeywordsBioequivalence
Chinese population
LC/ESI-MS
Pharmacokinetics
Trimetazidine
Issue Date2007
Citation
Journal of Pharmaceutical and Biomedical Analysis, 2007, v. 43, n. 5, p. 1804-1807 How to Cite?
AbstractA rapid liquid chromatography electrospray ionization mass spectrometry (LC/ESI-MS) method with good sensitivity and specificity has been developed and validated for the identification and quantification of trimetazidine in human plasma. Trimetazidine and lidocaine (internal standard) were isolated from plasma samples by protein precipitation with methanol. The chromatographic separation was accomplished on a Xterra MS C18 Column (150 mm × 4.6 mm, 5 μm particle size) with the mobile phase consisting of methanol and water (40:60, v/v) (pH 2.0, adjusted with trifluoroacetic acid), and the flow rate was set at 0.6 mL/min. Detection was performed on a single quadruple mass spectrometer by selected ion monitoring (SIM) mode (m/z 267.0 for trimetazidine and m/z 235.0 for lidocaine) with the retention time at about 3.47 and 5.05 min, respectively. The calibration curve for trimetazidine was satisfactory with regression coefficient 0.9995 over the range of 2.5-100 ng/mL in the plasma. The LOQ (S/N = 10) was accordingly 2.5 ng/mL. The intra-day and inter-day precision expressed as relative standard deviation was 2.83-6.10% and 4.83-5.82%. The method was successfully applied to investigate the bioequivalence between two kinds of tablets (test versus reference product) in 19 healthy male Chinese volunteers. After a single 20 mg dose for the test and reference product, the resulting mean of major pharmacokinetic parameters such as AUC0-24, AUC0-∞, Cmax, Tmax and t1/2 of trimetazidine were (673.1 ± 117.6 ng h mL-1 versus 652.3 ± 121.9 ng h mL-1), (717.1 ± 120.9 ng h mL-1 versus 692 ± 128.6 ng h mL-1), (74.85 ± 12.13 ng mL-1 versus 71.93 ± 14.32 ng mL-1), (2.312 ± 0.663 h versus 2.211 ± 0.608 h) and (4.785 ± 0.919 h versus 4.740 ± 0.823 h), respectively, indicating that these two kinds of tablets were bioequivalent in the Chinese population. © 2007 Elsevier B.V. All rights reserved.
Persistent Identifierhttp://hdl.handle.net/10722/342308
ISSN
2023 Impact Factor: 3.1
2023 SCImago Journal Rankings: 0.584
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorJiao, Yang-
dc.contributor.authorSu, Mingming-
dc.contributor.authorChen, Minjun-
dc.contributor.authorJia, Wei-
dc.contributor.authorChou, Yiqun-
dc.contributor.authorHuang, Zhongyi-
dc.contributor.authorYang, Nanlin-
dc.contributor.authorTong, Weida-
dc.date.accessioned2024-04-17T07:02:51Z-
dc.date.available2024-04-17T07:02:51Z-
dc.date.issued2007-
dc.identifier.citationJournal of Pharmaceutical and Biomedical Analysis, 2007, v. 43, n. 5, p. 1804-1807-
dc.identifier.issn0731-7085-
dc.identifier.urihttp://hdl.handle.net/10722/342308-
dc.description.abstractA rapid liquid chromatography electrospray ionization mass spectrometry (LC/ESI-MS) method with good sensitivity and specificity has been developed and validated for the identification and quantification of trimetazidine in human plasma. Trimetazidine and lidocaine (internal standard) were isolated from plasma samples by protein precipitation with methanol. The chromatographic separation was accomplished on a Xterra MS C18 Column (150 mm × 4.6 mm, 5 μm particle size) with the mobile phase consisting of methanol and water (40:60, v/v) (pH 2.0, adjusted with trifluoroacetic acid), and the flow rate was set at 0.6 mL/min. Detection was performed on a single quadruple mass spectrometer by selected ion monitoring (SIM) mode (m/z 267.0 for trimetazidine and m/z 235.0 for lidocaine) with the retention time at about 3.47 and 5.05 min, respectively. The calibration curve for trimetazidine was satisfactory with regression coefficient 0.9995 over the range of 2.5-100 ng/mL in the plasma. The LOQ (S/N = 10) was accordingly 2.5 ng/mL. The intra-day and inter-day precision expressed as relative standard deviation was 2.83-6.10% and 4.83-5.82%. The method was successfully applied to investigate the bioequivalence between two kinds of tablets (test versus reference product) in 19 healthy male Chinese volunteers. After a single 20 mg dose for the test and reference product, the resulting mean of major pharmacokinetic parameters such as AUC0-24, AUC0-∞, Cmax, Tmax and t1/2 of trimetazidine were (673.1 ± 117.6 ng h mL-1 versus 652.3 ± 121.9 ng h mL-1), (717.1 ± 120.9 ng h mL-1 versus 692 ± 128.6 ng h mL-1), (74.85 ± 12.13 ng mL-1 versus 71.93 ± 14.32 ng mL-1), (2.312 ± 0.663 h versus 2.211 ± 0.608 h) and (4.785 ± 0.919 h versus 4.740 ± 0.823 h), respectively, indicating that these two kinds of tablets were bioequivalent in the Chinese population. © 2007 Elsevier B.V. All rights reserved.-
dc.languageeng-
dc.relation.ispartofJournal of Pharmaceutical and Biomedical Analysis-
dc.subjectBioequivalence-
dc.subjectChinese population-
dc.subjectLC/ESI-MS-
dc.subjectPharmacokinetics-
dc.subjectTrimetazidine-
dc.titleLC/ESI-MS method for the determination of trimetazidine in human plasma: Application to a bioequivalence study on Chinese volunteers-
dc.typeArticle-
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1016/j.jpba.2006.11.040-
dc.identifier.pmid17208404-
dc.identifier.scopuseid_2-s2.0-33947355351-
dc.identifier.volume43-
dc.identifier.issue5-
dc.identifier.spage1804-
dc.identifier.epage1807-
dc.identifier.isiWOS:000246008300030-

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