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Stereoselective Determination of Ornidazole Enantiomers in Human Plasma and Urine Samples by Chiral LC: Application to Pharmacokinetic Study

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Abstract

A stereoselective liquid chromatographic method to determine the enantiomers of ornidazole in human plasma and urine has been developed and validated. After addition of the internal standard (naproxen), samples were acidified and extracted with diethyl ether. The separation was performed on a Chiralcel OB-H column, using hexane-ethanol- glacial acetic acid (94:6:0.08, v/v) as the mobile phase. The method was validated for specificity, linearity, sensitivity, precision, accuracy and stability. For each enantiomer of ornidazole, linear calibration curves were obtained over the concentration range of 0.16–20 μg mL−1 in plasma and 0.32–20 μg mL−1 in urine. For both enantiomers of ornidazole in plasma and urine, the coefficient of variation for precision were consistently less than 12% and accuracy were within ±14% in terms of relative error. Application of the method to a preliminary pharmacokinetic study showed that this validated method was qualified for the direct determination of ornidazole enantiomers in human plasma and urine.

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Acknowledgment

We are gratefully acknowledging the financial support of Jiangsu Key Lab of Drug Metabolism and Pharmacokinetics (No. BM2001201).

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Authors and Affiliations

  1. Key Laboratory of Drug Metabolism and Pharmacokinetics, China Pharmaceutical University, 210009, Nanjing, People’s Republic of China

    Huan Wang, Yan Chen, Jia Zhou, Chen Ma, Yuancheng Chen & Xiaoquan Liu

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  1. Huan Wang
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  2. Yan Chen
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  3. Jia Zhou
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  4. Chen Ma
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  5. Yuancheng Chen
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  6. Xiaoquan Liu
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Correspondence to Xiaoquan Liu.

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Wang, H., Chen, Y., Zhou, J. et al. Stereoselective Determination of Ornidazole Enantiomers in Human Plasma and Urine Samples by Chiral LC: Application to Pharmacokinetic Study. Chroma 67, 875–881 (2008). https://doi.org/10.1365/s10337-008-0625-3

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  • DOI: https://doi.org/10.1365/s10337-008-0625-3

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