Liquid chromatographic and spectroscopic characterization of pentamidine isethionate and impurities in bulk drug and injectables. NLM AIDSLINE Important note: Information in this article was accurate in 1986. The state of the art may have changed since the publication date.

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Liquid chromatographic and spectroscopic characterization of pentamidine isethionate and impurities in bulk drug and injectables.

J Assoc Off Anal Chem. 1986 Jul-Aug;69(4):624-9. Unique Identifier : AIDSLINE MED/86304107
Mount DL; Miles JW; Churchill FC

Abstract: A liquid chromatographic (LC) method is described for evaluating purity of pentamidine isethionate (PI), a life-saving drug used in the treatment of Pneumocystis carinii pneumonia, which is a leading cause of death in persons with acquired immunodeficiency syndrome (AIDS). Six potential impurity compounds were synthesized to test the selectivity of the chromatographic system and to permit quantitation of impurities in various lots of PI products. The drug and impurities were separated with gradient elution on a cyano-bonded LC column. The analytic system provided information on the identities and levels of impurities in early experimental lots of PI. These results assisted the manufacturer in altering reaction conditions and purification procedures to ensure that succeeding lots were within the specification limits, i.e., no more than 0.4% of any single impurity or 0.7% of total impurities found in the final product.
Keywords: Amidines/*ANALYSIS Chromatography, Liquid *Drug Contamination Pentamidine/*ANALYSIS Spectrophotometry, Ultraviolet JOURNAL ARTICLE

KWDamidines/KWDanalysischromatography,liquidKWDdrugcontaminationpentamidine/KWDanalysisspectrophotometry,ultravioletjournalarticle
861230
M86C0211

Copyright © 1986 - National Library of Medicine. Reproduced under license with the National Library of Medicine, Bethesda, MD.

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