Analysis of diltiazem and its related substances by HPLC and HPLC/MS.

Authors :: Quaglia MG
Donati E
Fanali S
Bossù E
Montinaro A
Buiarelli F
Source :: Journal of pharmaceutical and biomedical analysis [J Pharm Biomed Anal] 2005 Apr 01; Vol. 37 (4), pp. 695-701. Date of Electronic Publication: 2005 Jan 05.
Publication Year :: 2005
Abstract: Diltiazem (DTZ) is an optically active calcium channel blocker having a benzodiazepine structure. The drug used in therapy is (+)-cis-diltiazem with configuration (2S,3S). To describe the analytical profile of DTZ different stationary phases (RP-18, RP-8, monolithic support) were tested. The best separation of DTZ from A, B, E and F was obtained using as stationary phase a RP-8 or a monolithic RP-18. The characterization of impurities was carried out using two analytical systems, HPLC and HPLC/MS.