Liquid chromatographic and spectroscopic characterization of pentamidine isethionate and impurities in bulk drug and injectables.
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.
D000578:Amidines / Q000032:analysis*; D002853:Chromatography, Liquid; D004340:Drug Contamination; D010419:Pentamidine / Q000032:analysis*; D013056:Spectrophotometry, Ultraviolet
D000578:Amidines; D010419:Pentamidine