GLC method for iminodibenzyl and desipramine impurities in imipramine hydrochloride and its formulated products.

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 Sci

authors

Thompson DW

doi

10.1002/jps.2600710515

subject

Has Abstract

pub_date

1982-05-01 00:00:00

pages

536-8

issue

5

eissn

0022-3549

issn

1520-6017

pii

S0022-3549(15)44171-1

journal_volume

71

pub_type

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