Cefpiramide is frequently used to treat biliary infections. However, no bioanalytical method has been validated to quantitate cefpiramide in human samples, particularly in bile. Therefore, this study was conducted to develop a simple, selective and validated high‐performance liquid chromatographic method to determine cefpiramide in human plasma and bile. A protein precipitation procedure was used to extract cefpiramide and cefoperazone (internal standard, IS) from 200 μl of plasma and bile. Utilizing a Capcell Pak C₁₈ column (4.6 × 250 mm), cefpiramide and IS were separated using the timed‐gradient mobile phase consisting of 0.1 m sodium acetate (pH 5.2) and acetonitrile at a flow rate of 1 ml/min with photodiode array detector (wavelength set at 273 nm). The calibration curves showed linearity at concentrations ranging from 1 to 150 μg/ml in both plasma and bile (r² > 0.999). The within‐ and between‐run coefficients of variation (CVs) for plasma samples were 0.570–4.43 and 1.10–2.76%, respectively; for bile samples, the within‐ and between‐day precision (CV) was 0.814–6.34 and 2.05–4.00%, respectively. Our newly developed bioanalytical method was successfully employed to quantify cefpiramide concentrations in both plasma and bile at multiple time points in patients with acute cholangitis.

中文翻译：

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使用高效液相色谱法定量测定人类样品中血浆和胆汁中头孢吡胺的浓度。

头孢吡胺常用于治疗胆道感染。但是，尚未有任何生物分析方法可用于定量定量人类样品中，尤其是胆汁中的头孢吡胺。因此，进行这项研究是为了开发一种简单，选择性和经过验证的高效液相色谱方法，用于测定人血浆和胆汁中的头孢吡胺。使用蛋白质沉淀程序从200μl血浆和胆汁中提取头孢吡胺和头孢哌酮（内标，IS）。使用Capcell Pak C ₁₈色谱柱（4.6×250 mm），使用0.1 m的定时梯度流动相分离头孢吡胺和IS用光电二极管阵列检测器（波长设置为273 nm）以1 ml / min的流速过滤乙酸钠（pH 5.2）和乙腈。校准曲线在血浆和胆汁中的浓度范围为1至150μg/ ml时均显示线性（r ²  > 0.999）。血浆样品的运行内和运行间变异系数（CVs）分别为0.570-4.43和1.10-2.76％。对于胆汁样品，日内和日间精度（CV）分别为0.814–6.34和2.05–4.00％。我们新开发的生物分析方法已成功用于量化急性胆管炎患者多个时间点血浆和胆汁中头孢吡胺的浓度。