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PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
7
pubmed:dateCreated
1997-8-28
pubmed:abstractText
A capillary electrophoresis (CE) method utilizing indirect ultraviolet (UV) detection was developed for the determination of a non-UV absorbing degradation product, Ro 5-5172, in clidinium bromide drug substance. The electrophoresis buffer consisted of sodium phosphate and benzyltrimethylammonium bromide. Rinsing the capillary with sodium hydroxide followed by water then fresh capillary electrophoresis buffer was found to significantly improve the reproducibility of the migration times of the analytes. To further improve run-to-run reproducibility, an internal marker was used to account for differences in injection volumes and migration times between runs. The precision of the method was found to be less than 1% relative standard deviation for the migration time ratio and peak area ratio of Ro 5-5172 to the internal standard. The method was found to be linear for 0.05-1% Ro 5-5172 with respect to a 10 mg ml-1 sample preparation. The limit of detection was found to be less than 0.01% Ro 5-5172. Results obtained for the analysis of a clidinium bromide drug substance lot using this CE method and a thin layer chromatography method were compared and found to be in agreement.
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:volume
15
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
965-71
pubmed:dateRevised
2000-12-18
pubmed:meshHeading
pubmed:year
1997
pubmed:articleTitle
The determination of a degradation product in clidinium bromide drug substance by capillary electrophoresis with indirect UV detection.
pubmed:affiliation
Hoffmann-La Roche Inc., Nutley, NJ 07110, USA.
pubmed:publicationType
Journal Article