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首页> 外文期刊>Chromatographia >Stereoselective determination of ornidazole enantiomers in human plasma and urine samples by chiral LC: Application to pharmacokinetic study
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Stereoselective determination of ornidazole enantiomers in human plasma and urine samples by chiral LC: Application to pharmacokinetic study

机译：手性LC立体选择性测定人血浆和尿液中的奥硝唑对映异构体：在药代动力学研究中的应用

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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 mu g mL(-1) in plasma and 0.32-20 mu g 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.
机译：建立并验证了测定人血浆和尿液中奥硝唑对映体的立体选择性液相色谱方法。加入内标（萘普生）后，酸化样品并用乙醚萃取。分离在Chiralcel OB-H色谱柱上进行，使用己烷-乙醇-冰醋酸（94：6：0.08，v / v）作为流动相。验证了该方法的特异性，线性，灵敏度，精密度，准确性和稳定性。对于奥硝唑的每种对映异构体，在血浆中0.16-20μgmL（-1）和尿液中0.32-20μgmL（-1）的浓度范围内获得线性校准曲线。对于血浆和尿液中奥硝唑的两种对映异构体，相对误差的精度变异系数始终小于12％，精度误差在+/- 14％之内。该方法在初步药代动力学研究中的应用表明，该验证方法适用于直接测定人血浆和尿液中的奥硝唑对映体。

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