Source:http://linkedlifedata.com/resource/pubmed/id/19411156
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Predicate | Object |
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rdf:type | |
lifeskim:mentions | |
pubmed:issue |
1
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pubmed:dateCreated |
2009-5-26
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pubmed:abstractText |
An accurate and reproducible high-performance liquid chromatographic (HPLC) method has been developed and validated for the direct separation of individual enantiomers of lansoprazole, a potent proton pump inhibitor belonging to the family of the substituted benzimidazoles. The enantiomers were resolved on a Chiralpak IA by using a mobile phase consisting of methyl-tert-butyl ether (MtBE)-ethyl acetate (EA)-ethanol (EtOH)-diethylamine (DEA) in the ratio 60:40:5:0.1 (v/v/v/v). Baseline separation of the enantiomers of lansoprazole was obtained with a resolution factor of 8.14. The standard curves for the two enantiomers were linear (r(2)>0.999) in the concentration range of 10-80microg/ml with a working concentration of about 60microg/ml for each enantiomer. Apparent recovery was 100.8% with a relative standard deviation less than 2%. The limit of quantization for each enantiomer of lansoprazole was 0.22microg/ml. The intra-day precisions were in the range of 0.21-0.36 and 0.59-0.66 while the inter-day precisions were in the range of 0.55-1.24 and 0.66-1.19% in terms of retention times and area response RSD% for (R)-(+)- and (S)-(-)-lansoprazole, respectively. The method was also able to resolve impurities from the enantiomers of lansoprazole.
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pubmed:language |
eng
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pubmed:journal | |
pubmed:citationSubset |
IM
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pubmed:chemical | |
pubmed:status |
MEDLINE
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pubmed:month |
Aug
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pubmed:issn |
1873-264X
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pubmed:author | |
pubmed:issnType |
Electronic
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pubmed:day |
15
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pubmed:volume |
50
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
9-14
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pubmed:meshHeading |
pubmed-meshheading:19411156-2-Pyridinylmethylsulfinylbenzimidazoles,
pubmed-meshheading:19411156-Chromatography, High Pressure Liquid,
pubmed-meshheading:19411156-Reference Standards,
pubmed-meshheading:19411156-Reproducibility of Results,
pubmed-meshheading:19411156-Sensitivity and Specificity,
pubmed-meshheading:19411156-Stereoisomerism
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pubmed:year |
2009
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pubmed:articleTitle |
Development and validation of an enantioselective and chemoselective HPLC method using a Chiralpak IA column to simultaneously quantify (R)-(+)- and (S)-(-)-lansoprazole enantiomers and related impurities.
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pubmed:affiliation |
Department of Therapeutic Research and Medicines Evaluation, Istituto Superiore di Sanità, Rome, Italy.
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pubmed:publicationType |
Journal Article,
Validation Studies
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