Alam Md Tauquir, Mujtaba Md Ali, Hussain Afzal, Ali Abuzer, Imran Mohd, Barkat Md Abul, Abdel-Gawad Sherif A
Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Northern Border University, Rafha 91911, Saudi Arabia.
Department of Pharmaceutics, Faculty of Pharmacy, Northern Border University, Rafha 91911, Saudi Arabia.
J Chromatogr Sci. 2023 Apr 24;61(4):366-374. doi: 10.1093/chromsci/bmac054.
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.
采用液相色谱 - 串联质谱技术结合电喷雾电离，开展了生物敏感分析方法的开发与验证，以准确、快速地定量测定人血浆中的头孢地尼（CDR）。分析使用C18柱，流速为1.0 mL/min，操作温度为30.0 ±1°C。通过分别优化头孢地尼和内标（IS）的m/z比396.20→227.20和428.17→241.10来洗脱药物。头孢地尼的日内精密度（%CV）在质量控制定量下限（LLOQ QC）时为2.8%，在质量控制定量上限（HQC QC）时为6.7%，而日间精密度后，LLOQ和HQC的这些值分别为3.0%和5.6%。此外，准确度在107.70%（HQC QC）至95.5%（LLOQ QC）之间。头孢地尼的提取平均回收率为83.91±6.0%，内标的提取平均回收率为76.7±6.23%。在整个分析期间，药物保持稳定。由于每个样品的运行时间<2.5分钟，因此每天可以分析多个血浆样品。该方法成功地定量测定了人血浆中的CDR，随后得到的药代动力学曲线简单、准确、灵敏且具有成本效益。
