Determination of Hydrazine in Pharmaceuticals III: Hydralazine and Isoniazid Using GLC

□ A GLC procedure has been developed for the determination of hydrazine in hydralazine and isoniazid drug raw materials, single and multicomponent tablets, injectables, and syrups. The method is based on the derivatization of hydrazine with benzaldehyde to form benzalazine. The minimum detectable am...

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Bibliographic Details
Published in:Journal of pharmaceutical sciences 1983-08, Vol.72 (8), p.948-951
Main Authors: Matsui, F., Robertson, D.L., Lovering, E.G.
Format: Article
Language:English
Subjects:
Chemistry, Pharmaceutical
Chromatography, Gas - methods
determination of hydrazine
Drug Combinations
Drug Contamination
Drug Storage
GLC-determination of hydrazine in pharmaceutics
GLC—determination of hydrazine in pharmaceutics, hydralazine, isoniazid
hydralazine
Hydralazine - analysis
Hydralazine-GLC
Hydralazine—GLC, determination of hydrazine
Hydrazine-determination in hydralazine and isoniazid by GLC
Hydrazines - analysis
isoniazid
Isoniazid - analysis
Isoniazid-GLC
Isoniazid—GLC, determination of hydrazine
Solutions - analysis
Tablets - analysis
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Summary:□ A GLC procedure has been developed for the determination of hydrazine in hydralazine and isoniazid drug raw materials, single and multicomponent tablets, injectables, and syrups. The method is based on the derivatization of hydrazine with benzaldehyde to form benzalazine. The minimum detectable amount of hydrazine in hydralazine and isoniazid raw materials and formulations is ~0.0003%. No hydrazine was found in the hydralazine raw material specimens examined. Traces of hydrazine (~0.0003%) were found in some tablet lots and ~0.02% was found in an injectable product. A trace of hydrazine was found in one lot of isoniazid raw material and low levels (0.0012 and 0.0029%) were found in isoniazid tablet products. An isoniazid syrup contained ~0.2% hydrazine.
ISSN:0022-3549
1520-6017
DOI:10.1002/jps.2600720829