Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
1
pubmed:dateCreated
2003-7-10
pubmed:abstractText
Two chiral HPLC methods namely method A and method B were developed for the separation of enantiomers of Linezolid. The mobile phases containing hexane, 2-propanol and trifluoro acetic acid (TFA) in the ratio (80:20:0.1, v/v/ v); hexane, ethanol and TFA in the ratio (65:35:0.1, v/v/v) were used in method A and method B, respectively. The assay results of the two methods were checked in terms of F-test variance ratio and found to be less than the table value, confirming their good precision. The enantiomeric separation of Linezolid on different chiral stationary phases was investigated. The two enantiomers of Linezoild were well resolved on a Chiralpak AD, an amylose based stationary phase. Preparative chiral HPLC was carried out to obtain pure (+) enantiomer of Linezolid from its racemate. The method A was extensively validated and found to be robust. The chiral assay of Linezolid in bulk and pharmaceutical formulations (tablet) were found to be 100.4 +/- 0.4 and 101.2 +/- 1.4%, respectively at 95% confidence interval. The percentage recovery of (+) enantiomer (chiral impurity) was found to be 99.2 +/- 1.9 at 95% confidence interval. The limit of detection and limit of quantification of (+) enantiomer were found to be 123 and 374 ng/ml, respectively for 10 microl injection volume.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Apr
pubmed:issn
0731-7085
pubmed:author
pubmed:issnType
Print
pubmed:day
24
pubmed:volume
32
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
21-8
pubmed:meshHeading
pubmed:year
2003
pubmed:articleTitle
A validated chiral HPLC method for the enantiomeric separation of Linezolid on amylose based stationary phase.
pubmed:affiliation
Custom Chemical Services, Dr Reddy's Laboratories Ltd, 7-1-27, Ameerpet, Hyderabad 500016, India.
pubmed:publicationType
Journal Article