快速灵敏的LC-MS/MS法测定人血浆中阿莫西林并应用于两种制剂的一致性评价

目的: 建立快速灵敏的LC-MS/MS法测定人血浆中阿莫西林浓度，并用于两种阿莫西林胶囊的一致性评价。方法: 采用岛津公司LCMS-8060型LC-MS/MS仪，以MRM模式测定阿莫西林（m/z 366.00/114.00）的浓度，d4-阿莫西林作内标（m/z 370.10/114.05），离子源为ESI源。色谱柱选用Waters ACQUITY BEH C18（2.1×50 mm，1.7 μm），梯度洗脱。血浆样本加入内标，经甲醇沉淀蛋白后取上清液进样检测。结果: 所建方法经验证，其线性、准确度、精密度、最低定量限、提取回收率、特异性、基质效应、稳定性等各项指标均符合CFDA的指导原则及最新核查标准要求，并较文献报道中的方法有处理简单、灵敏度高、色谱峰形好的优点。结论: 所建方法快速、灵敏，适用于人血浆中阿莫西林浓度的检测。用于一致性评价的样本实测，两种制剂生物等效。

Rapid and sensitive determination of amoxicillin in human plasma by LC-MS/MS and the bioavailability of two amoxicillin capsules

AIM: To establish a rapid and sensitive LC-MS/MS method for determination of amoxicillin in human plasma and to study the bioavailability of two amoxicillin capsules. METHODS: Shimadzu LCMS-8060 series LC-MS/MS was used. Amoxicillin（m/z 366.00/114.00）and d4-amoxicillin (internal standard, m/z 370.10/114.05) were monitored by ESI in MRM model. The analysts were eluted on Waters ACQUITY BEH C18 column ( 2.1×50 mm，1.7 μm) according to gradient elution program. The plasma samples were mixed with internal standard, then precipitated protein by methanol, the supernatants were detected. RESULTS: The linear, accuracy, precision, LLOQ, extraction recovery, specificity, matrix effect, stability of our method all met the guiding principles and criteria of CFDA. Compared with the literature reports, our method was simple, rapid, sensitive and had better chromatographic peaks. CONCLUSION: The method is rapid, sensitive and suitable for the determination of amoxicillin in human plasma. The test capsule is bioequivalence to the reference capsule.