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人血浆中头孢他啶、阿维巴坦及氨曲南浓度同时测定方法的建立
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| 篇名： | 人血浆中头孢他啶、阿维巴坦及氨曲南浓度同时测定方法的建立 |
| TITLE： | Establishment of a method for simultaneous determination of ceftazidime，avibactam and aztreonam concentrations in human plasma |
| 摘要： | 目的 建立同时测定人血浆中头孢他啶、阿维巴坦及氨曲南浓度的方法。方法以稳定同位素标记物头孢他啶-D5、阿维巴坦-13C5、氨曲南-2H6为内标，以甲醇沉淀蛋白结合氮吹浓缩的方法进行血浆样品前处理，采用超高效液相色谱-串联质谱（UPLC-MS/MS）技术建立同时测定人血浆中头孢他啶、阿维巴坦及氨曲南浓度的定量分析方法。以ACQUITYUPLCBEHC18柱为色谱柱，以0.01%甲酸-乙腈溶液为流动相进行梯度洗脱，流速为0.3mL/min，柱温为40℃，进样量为5μL，并采用电喷雾离子源在正、负离子模式下进行多反应监测；然后根据2020年版《中国药典》（四部）“生物样品定量分析方法验证指导原则”进行方法学验证。结果头孢他啶、阿维巴坦及氨曲南的线性范围分别为0.04～200、0.05～50、0.01～50μg/mL（r均不小于0.996），准确度的相对误差（RE）均不大于12.25%（n＝5），精密度的RSD均不大于13.49%（n＝5），内标归一化基质因子的RSD均小于15.00%（n＝6），稳定性试验的RE均小于15.00%（n＝3）。结论本研究成功建立了同时测定人血浆中头孢他啶、阿维巴坦及氨曲南浓度的UPLC-MS/MS方法，该方法具有良好的准确度、精密度和稳定性，可为接受头孢他啶-阿维巴坦联合氨曲南治疗患者的血药浓度监测及个体化给药提供方法学支持。 |
| ABSTRACT： | OBJECTIVE To establish a method for simultaneous determination of ceftazidime， avibactam and aztreonam concentrations in human plasma.METHODS Stable-isotope-labeled compounds ceftazidime-D 5 ， avibactam- 13 C 5 and aztreonam- 2 H 6 were used as internal standards. Plasma samples were pretreated by protein precipitation with methanol， followed by nitrogen blowing. A ultra-performance liquid chromatography-tandem mass spectrometry （UPLC-MS/MS） technique was applied to develop a quantitative analytical method for simultaneous measurement of ceftazidime， avibactam and aztreonam in human plasma. An ACQUITY UPLC BEH C 18 column was used as the chromatographic column. Gradient elution was performed with 0.01% formic acid-acetonitrile solution as the mobile phase at a flow rate of 0.3 mL/min. The column temperature was set at 40 ℃， and the injection volume was 5 μL. An electrospray ionization source was operated in both positive and negative ion modes for multiple reaction monitoring. Method validation was carried out according to the Guidelines for Bioanalytical Method Validation contained in volume Ⅳ of the 2020 edition of Chinese Pharmacopoeia .RESULTS The linear ranges of ceftazidime， avibactam and aztreonam were 0.04-200， 0.05-50，0.01-50 μg/mL， respectively， with all correlation coefficients no less than 0.996. The relative error （RE） for accuracy was no more than 12.25% （ n ＝5）， and the RSD for precision was no more than 13.49% （ n ＝5）. The RSD of internal-standard-normalized matrix factors was less than 15.00% （ n ＝6）. The RE in stability tests was lower than 15.00% （ n ＝3）.CONCLUSIONS This study successfully established an UPLC-MS/MS method for simultaneous determination of ceftazidime， avibactam and aztreonam concentrations in human plasma. The method possesses favorable accuracy， precision and stability， and can provide methodological support for therapeutic drug monitoring and individualized medication in patients treated with these three combined drugs. |
| 期刊： | 2026年第37卷第17期 |
| 作者： | 翁莉莉；张弋；张瑞霞；吕雅瑶；朱成 |
| AUTHORS： | WENG Lili，ZHANG Yi，ZHANG Ruixia，LYU Yayao，ZHU Cheng |
| 关键字： | 超高效液相色谱-串联质谱法；头孢他啶；阿维巴坦；氨曲南；血药浓度；感染 |
| KEYWORDS： | ceftazidime;avibactam;aztreonam;plasma concentration;infection |
| 阅读数： | 1 次 |
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