Abstract:
:A GLC method is described for the determination of iminodibenzyl and desipramine impurities in imipramine hydrochloride and its formulated products. These impurities were extracted from an alkaline solution with a mixture of 30% methylene chloride in hexane for chromatography on a 3% OV-17 GLC column. Iminodibenzyl was determined using anthracene as an internal standard and desipramine was determined (after derivatization) using nortriptyline as an internal standard. Based on spiked excipient mixtures typically used to compound imipramine tablets, recoveries were 93-109% for iminodibenzyl and 93-107% for desipramine at 0.2-0.4% of the labeled claim of imipramine. Minimum detection levels were approximately 0.02% for each impurity, and procedural standards gave coefficients of variation of less than 1% for each impurity. The method was linear in the 0.05-0.5 microgram range and typically gave correlation coefficients greater than or equal to 0.999.
journal_name
J Pharm Scijournal_title
Journal of pharmaceutical sciencesauthors
Thompson DWdoi
10.1002/jps.2600710515subject
Has Abstractpub_date
1982-05-01 00:00:00pages
536-8issue
5eissn
0022-3549issn
1520-6017pii
S0022-3549(15)44171-1journal_volume
71pub_type
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journal_title:Journal of pharmaceutical sciences
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更新日期:1981-04-01 00:00:00
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更新日期:1994-05-01 00:00:00
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pub_type: 临床试验,杂志文章
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更新日期:2004-08-01 00:00:00