A biosensitive analysis method development and validation was performed for accurate and rapid quantification of cefdinir (CDR) in human plasma by a liquid chromatography–tandem mass spectrometry technique coupled with electrospray ionization. Analysis was carried out using a C18 column with a flow rate of 1.0 mL/min and operating temperature of 30.0 ± 1°C. The drug was eluted by optimizing the m/z ratios of 396.20 → 227.20 and 428.17 → 241.10, for cefdinir and IS (internal standard), respectively. The intraday precision (%CV) for Cefdinir ranged from 2.8% and 6.7% as lower limit of quantification of quality control (LLOQ QC) and higher level of quantification of quality control (HQC QC), respectively, whereas these value were found to be as 3.0% and 5.6% for LLOQ and HQC, respectively after interday precision. Moreover, accuracy ranged from 107.70% (HQC QC) to 95.5% (LLOQ QC). The extraction mean recovery was found to be 83.91 ± 6.0% for cefdinir and 76.7 ± 6.23% for IS. The drug was stable throughout the analysis period. It was possible to analyze several plasma samples every day since each sample took <2.5 min to run. The method demonstrated successful quantification of CDR in human plasma, followed by pharmacokinetic profiles that were simple, accurate, sensitive and cost-effective.

中文翻译：

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使用液相色谱-串联质谱法 (LC-MS/MS) 的固相萃取 (SPE) 技术定量人血浆中的头孢地尼

通过液相色谱-串联质谱技术结合电喷雾电离，对人血浆中的头孢地尼 (CDR) 进行了准确、快速定量的生物敏感分析方法开发和验证。使用 C18 色谱柱进行分析，流速为 1.0 mL/min，操作温度为 30.0 ± 1°C。通过分别针对头孢地尼和 IS（内标）优化 396.20 → 227.20 和 428.17 → 241.10 的 m/z 比来洗脱药物。头孢地尼的日内精密度 (%CV) 分别为质量控制定量下限 (LLOQ QC) 和质量控制定量较高水平 (HQC QC) 的 2.8% 和 6.7%，而这些值被发现是LLOQ 和 HQC 在日间精密度后分别为 3.0% 和 5.6%。此外，准确度范围为 107。70%（HQC QC）至 95.5%（LLOQ QC）。头孢地尼的提取平均回收率为 83.91 ± 6.0%，内标为 76.7 ± 6.23%。该药物在整个分析期间是稳定的。由于每个样品的运行时间小于 2.5 分钟，因此每天可以分析多个血浆样品。该方法证明了人血浆中 CDR 的成功量化，随后是简单、准确、灵敏且具有成本效益的药代动力学特征。