Source:http://linkedlifedata.com/resource/pubmed/id/16287036
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rdf:type | |
lifeskim:mentions | |
pubmed:issue |
12
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pubmed:dateCreated |
2005-12-6
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pubmed:abstractText |
A rapid, sensitive and specific high-performance liquid chromatography-electrospray ionization mass spectrometry (LC/ESI-MS) method was developed and validated for the first time to determine the concentration of lafutidine in human plasma. After the addition of diazepam (the internal standard, IS) and 1 M sodium hydroxide solution to 0.5-ml plasma sample, lafutidine was extracted from plasma with n-hexane : isopropanol (95 : 5, v/v). The organic layer was evaporated and the residue was redissolved in 200-microl mobile phase. The analyte was chromatographically separated on a prepacked Shimadzu Shim-pack VP-ODS C(18) column (250 x 2.0 mm i.d.) using a mixture of methanol-water (20 mM CH(3)COONH(4)) = 80 : 20 (v/v) as mobile phase. Detection was performed on a single quadrupole mass spectrometer using an electrospray ionization interface and the selected-ion monitoring (SIM) mode. The method showed excellent linearity (r = 0.9993) over the concentration range of 5-400 ng/ml and had good accuracy and precision. The within- and between-batch precisions were within 10% relative standard deviation. The limit of detection was 1 ng/ml. The validated LC/ESI-MS method has been successfully applied to the bioequivalence study of lafutidine in 24 healthy male Chinese volunteers.
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pubmed:language |
eng
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pubmed:journal | |
pubmed:citationSubset |
IM
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pubmed:chemical |
http://linkedlifedata.com/resource/pubmed/chemical/Acetamides,
http://linkedlifedata.com/resource/pubmed/chemical/Histamine H2 Antagonists,
http://linkedlifedata.com/resource/pubmed/chemical/Piperidines,
http://linkedlifedata.com/resource/pubmed/chemical/Pyridines,
http://linkedlifedata.com/resource/pubmed/chemical/lafutidine
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pubmed:status |
MEDLINE
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pubmed:month |
Dec
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pubmed:issn |
1076-5174
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pubmed:author | |
pubmed:issnType |
Print
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pubmed:volume |
40
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
1637-43
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pubmed:meshHeading |
pubmed-meshheading:16287036-Acetamides,
pubmed-meshheading:16287036-Chromatography, High Pressure Liquid,
pubmed-meshheading:16287036-Drug Stability,
pubmed-meshheading:16287036-Histamine H2 Antagonists,
pubmed-meshheading:16287036-Humans,
pubmed-meshheading:16287036-Male,
pubmed-meshheading:16287036-Piperidines,
pubmed-meshheading:16287036-Pyridines,
pubmed-meshheading:16287036-Reproducibility of Results,
pubmed-meshheading:16287036-Sensitivity and Specificity,
pubmed-meshheading:16287036-Spectrometry, Mass, Electrospray Ionization,
pubmed-meshheading:16287036-Therapeutic Equivalency
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pubmed:year |
2005
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pubmed:articleTitle |
Determination of lafutidine in human plasma by high-performance liquid chromatography-electrospray ionization mass spectrometry: application to a bioequivalence study.
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pubmed:affiliation |
Center for Instrumental Analysis, China Pharmaceutical University, Nanjing 210009, P. R. China.
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pubmed:publicationType |
Journal Article,
Validation Studies
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