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 ~0.02% for each impurity, and procedural standards gave coefficients of variation of <1% for each impurity. The method was linear in the 0.05-0.5 μg range and typically gave correlation coefficients ≥0.999.
Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
