Chiral separation of rac-Ornidazole and detection of the impurity of (R)-Ornidazole in (S)-Ornidazole injection and raw material |
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Authors: | Huang Jianquan Cao Guoying Hu Xin Sun Chunhua Zhang Junren |
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Institution: | Institute of Pharmaceutical Analysis, College of Pharmacy, Shandong University, P.R. China. jianquanhuang@mail.sdu.edu.cn |
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Abstract: | (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). |
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Keywords: | normal‐phase high‐performance liquid chromatography chiral separation (S)‐Ornidazole (R)‐Ornidazole impurity detection |
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