Chiral separation of rac-Ornidazole and detection of the impurity of (R)-Ornidazole in (S)-Ornidazole injection and raw material.
(S)-Ornidazole is a subject of research as an antifertility agent in male animals at present. However, there seems to be no relative report on chiral separation for rac-Ornidazole, which has been used as an effective medicine for more than 30 years. In this article, the chiral separation of rac-Ornidazole on a Chiralcel OB-H column based on normal-phase high-performance liquid chromatography (NP-HPLC) is investigated and the methodology for detection of impurity of (R)-Ornidazole in (S)-Ornidazole injection and raw material is established. The novel mobile phase is utilized by mixing n-hexane, methanol and isopropyl alcohol (95:4:1, v/v/v) instead of the typical mobile phase of n-hexane and isopropyl alcohol, although the methanol, which offers a good resolution factor for the enantiomeric separation in this system, is not recommended on the Chiralcel OB-H column according to the instruction supplied by Daicel Chemical Ind., LTD (Japan).
Huang
Jianquan
J
Institute of Pharmaceutical Analysis, College of Pharmacy, Shandong University, P.R. China. jianquanhuang@mail.sdu.edu.cn
Cao
Guoying
G
Hu
Xin
X
Sun
Chunhua
C
Zhang
Junren
J
D019840:2-Propanol / Q000737:chemistry; D000818:Animals; D002138:Calibration; D002851:Chromatography, High Pressure Liquid / Q000295:instrumentation / Q000379:methods; D003272:Contraceptive Agents, Male / Q000032:analysis / Q000737:chemistry / Q000302:isolation & purification* / Q000592:standards; D004340:Drug Contamination; D004355:Drug Stability; D006586:Hexanes / Q000737:chemistry; D008297:Male; D015394:Molecular Structure; D009950:Ornidazole / Q000032:analysis / Q000737:chemistry / Q000302:isolation & purification* / Q000592:standards; D015203:Reproducibility of Results; D012996:Solutions / Q000737:chemistry; D013237:Stereoisomerism
D003272:Contraceptive Agents, Male; D006586:Hexanes; D012996:Solutions; C026385:n-hexane; D009950:Ornidazole; D019840:2-Propanol