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Rapid Determination of Ranitidine in Human Plasma by Liquid Chromatography-Tandem Mass Spectrometry and Its Application to a Clinical Pharmacokinetic Study
Alternative TitleRapid Determination of Ranitidine in Human Plasma by Liquid Chromatography-Tandem Mass Spectrometry and Its Application to a Clinical Pharmacokinetic Study
Zhang Chao1; Wang Lu2; Guan Xin1; Fawcett J Paul3; Zhao Limei2; Sun Yantong1; Gu Jingkai1
2010
Source PublicationCHEMICAL RESEARCH IN CHINESE UNIVERSITIES
ISSN1005-9040
Volume26Issue:6Pages:910-914
AbstractA rapid and sensitive assay based on high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) was developed for the determination of ranitidine(RAN) in human plasma with codeine as internal standard(IS). After protein precipitation with acetonitrile, the analyte and IS were separated on a Zorbax SB-Aq C-18 column(150 mmx4.6 mm i. d., 5 mu m) eluted with a mobile phase consisting of methanol/acetonitrile/10 mmol/L ammonium acetate containing 1% formic acid(pH=2.4)(volume ratio 12.5:12.5:75) at a flow rate of 1.0 mL/min. Detection was performed by electrospray ionization in the positive ion mode followed by the multiple reaction monitoring(MRM) of the transitions of RAN at m/z 315.1 -> 176.3 and of IS at m/z 300.1 -> 165.1. The method was linear over a concentration range of 1-1000 ng/mL(r=0.9991) with a lower limit of quantitation(LLOQ) of 1 ng/mL and a limit of detection(LOD) of 0.3 ng/mL. Accuracy as relative error was from -0.01% to -1.7% and intra-day and inter-day precisions as relative standard deviation were <= 8.9% and <= 5.5%, respectively. The method was successfully applied to a pharmacokinetic study of ranitidine, getting a single oral dose(160 mg) to healthy volunteers.
Other AbstractA rapid and sensitive assay based on high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS)was developed for the determination of ranitidine(RAN)in human plasma with codeine as internal standard(IS).After protein precipitation with acetonitrile,the analyte and IS were separated on a Zorbax SB-Aq C18 column(150 mm×4.6 mm i.d.,5μm)eluted with a mobile phase consisting of methanol/acetonitrile/10 mmol/L ammonium acetate containing 1%formic acid(pH=2.4)(volume ratio 12.5:12.5:75)at a flow rate of 1.0 mL/min.Detection was performed by electrospray ionization in the positive ion mode followed by the multiple reaction monitoring(MRM)of the transitions of RAN at m/z 315.1→176.3 and of IS at m/z 300.1→165.1.The method was linear over a concentration range of 1―1000 ng/mL(r=0.9991)with a lower limit of quantitation(LLOQ)of 1 ng/mL and a limit of detection(LOD)of 0.3 ng/mL.Accuracy as relative error was from-0.01%to-1.7%and intra-day and inter-day precisions as relative standard deviation were≤8.9%and≤5.5%,respectively.The method was successfully applied to a pharmacokinetic study of ranitidine,getting a single oral dose(160 mg)to healthy volunteers
KeywordFAMOTIDINE HPLC BIOEQUIVALENCE METABOLITES NIZATIDINE VOLUNTEERS ASSAY Ranitidine Pharmacokinetics Human plasma Protein precipitation LC-MS/MS
Indexed ByCSCD
Language英语
Funding Project[National High-Tech Research and Development Program of China] ; [National Natural Science Foundation of China]
CSCD IDCSCD:4093582
Citation statistics
Document Type期刊论文
Identifierhttp://ir.imr.ac.cn/handle/321006/154156
Collection中国科学院金属研究所
Affiliation1.吉林大学
2.中国科学院金属研究所
3.University Otago, Sch Pharm, Dunedin, New Zealand
Recommended Citation
GB/T 7714
Zhang Chao,Wang Lu,Guan Xin,et al. Rapid Determination of Ranitidine in Human Plasma by Liquid Chromatography-Tandem Mass Spectrometry and Its Application to a Clinical Pharmacokinetic Study[J]. CHEMICAL RESEARCH IN CHINESE UNIVERSITIES,2010,26(6):910-914.
APA Zhang Chao.,Wang Lu.,Guan Xin.,Fawcett J Paul.,Zhao Limei.,...&Gu Jingkai.(2010).Rapid Determination of Ranitidine in Human Plasma by Liquid Chromatography-Tandem Mass Spectrometry and Its Application to a Clinical Pharmacokinetic Study.CHEMICAL RESEARCH IN CHINESE UNIVERSITIES,26(6),910-914.
MLA Zhang Chao,et al."Rapid Determination of Ranitidine in Human Plasma by Liquid Chromatography-Tandem Mass Spectrometry and Its Application to a Clinical Pharmacokinetic Study".CHEMICAL RESEARCH IN CHINESE UNIVERSITIES 26.6(2010):910-914.
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