Mulubwa Mwila, Mugabo Pierre
School of Pharmacy, University of the Western Cape, Bellville, Cape Town, South Africa.
Biomed Chromatogr. 2018 Nov;32(11):e4325. doi: 10.1002/bmc.4325. Epub 2018 Jul 12.
A chromatographic method has been developed and validated for the first time for analysis of terizidone in plasma. Terizidone was extracted from plasma by protein precipitation using a mixture of acetonitrile and methanol (1:1, v/v). The chromatographic separation was achieved with a gradient of acetonitrile and water both containing 0.1% formic acid on a Supelco Discovery HS C (150 × 4.6 mm, 5 μm) reversed-phase column. Propranolol was used as the internal standard. The total run-time was 18 min. The calibration standard concentrations ranged between 3.125 and 200 μg/mL and calibration curves were linear with coefficient of determination values in the range of 0.9988-0.9999. The inter- and intra-day assay precision (percentage relative standard error) was <15% while mean accuracy was 107%. The mean extraction efficiencies of terizidone and IS were 76 and 89%, respectively. The validation results demonstrated that the method was selective and sensitive, and that terizidone was stable under the studied conditions. The method was successfully applied in a population pharmacokinetic study. The mean plasma concentration of terizidone in patients at all sampling time points was 51.8 ± 28 μg/mL. The method was simple, cheap and hence suitable for therapeutic drug monitoring of terizidone.
首次开发并验证了一种用于分析血浆中氨己烯酸的色谱方法。采用乙腈和甲醇的混合物（1:1，v/v）通过蛋白沉淀法从血浆中提取氨己烯酸。在Supelco Discovery HS C（150×4.6 mm，5μm）反相柱上，使用含0.1%甲酸的乙腈和水的梯度洗脱实现色谱分离。以普萘洛尔作为内标。总运行时间为18分钟。校准标准浓度范围为3.125至200μg/mL，校准曲线呈线性，决定系数值在0.9988 - 0.9999范围内。日间和日内测定精密度（相对标准误差百分比）<15%，而平均准确度为107%。氨己烯酸和内标的平均提取效率分别为76%和89%。验证结果表明该方法具有选择性和灵敏性，且氨己烯酸在所研究的条件下稳定。该方法成功应用于群体药代动力学研究。在所有采样时间点，患者血浆中氨己烯酸的平均浓度为51.8±28μg/mL。该方法简单、成本低，因此适用于氨己烯酸的治疗药物监测。
