Analysis of diltiazem and its related substances by HPLC and HPLC/MS.
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.
Quaglia
M G
MG
Dipartimento Studi Farmaceutici, Università degli Studi di Roma La Sapienza, Piazzale Aldo Moro 5, Rome 00185, Italy. mariagiovanna.quaglia@uniroma1.it
Donati
E
E
Fanali
S
S
Bossù
E
E
Montinaro
A
A
Buiarelli
F
F
D002121:Calcium Channel Blockers / Q000032:analysis* / Q000302:isolation & purification; D002851:Chromatography, High Pressure Liquid; D004110:Diltiazem / Q000032:analysis* / Q000302:isolation & purification; D004340:Drug Contamination; D007202:Indicators and Reagents; D013058:Mass Spectrometry; D013237:Stereoisomerism
D002121:Calcium Channel Blockers; D007202:Indicators and Reagents; D004110:Diltiazem