High-Performance Liquid Chromatography Method for Assay of Diltiazem Hydrochloride and Its Related Compounds in Bulk Drug and Finished Tablets

Autor: Lacroix, Pauline M., Beaulieu, Normand, Cyr, Terry D., Lovering, Edward G.
Zdroj: Journal of Pharmaceutical Sciences; March 1989, Vol. 78 Issue: 3 p243-246, 4p
Abstrakt: The method provides for the resolution oftrans-diltiazem and seven known and several unknown related compounds from diltiazem HCl. Minimum detectable amounts were <0.1%, except for an intermediate which originates early in the synthetic process, for which the sensitivity is ∼2%. The relative standard deviation of the assay procedure is 0.15%. Total related compounds in four bulk drug and four tablet samples were <0.25%. The specific rotation of four samples of diltiazem HCl analyzed in duplicate was between +112 and +114°. The UV absorption spectra of all compounds exhibited two maxima, one between 203 and 213nm and the other between 230 and 244nm.
Databáze: Supplemental Index