Faculty of Medical Sciences, Department of Clinical Pathology, University of Campinas- UNICAMP, Campinas, SP, Brazil.
J Mass Spectrom. 2011 Dec;46(12):1269-73. doi: 10.1002/jms.2014.
Using enalapril maleate as a test case, the ability of ambient mass spectrometry, namely, via easy ambient sonic-spray ionization mass spectrometry (EASI-MS), to perform direct monitoring of drug degradation has been tested. Two manufacturing processes were investigated (direct compression and wet granulation), and the formation of degradation products was measured via both EASI-MS and high-performance liquid chromatography with ultraviolet detection for a total period of 18 months. Both techniques provide comparable results, which indicate that direct analysis by ambient mass spectrometric techniques presents a viable alternative for drug degradation monitoring with superior simplicity, throughput, and reliability (no sample manipulation), and comparable quantitative results. In terms of qualitative monitoring, the full mass spectra with intact species provided by EASI-MS allow for comprehensive monitoring of known and unknown (or unexpected) degradation products.
采用马来酸依那普利作为测试案例，检验了环境质谱（即通过简单的环境声波喷雾电离质谱（EASI-MS））进行药物降解直接监测的能力。研究了两种制造工艺（直接压缩和湿法制粒），通过 EASI-MS 和高效液相色谱-紫外检测两种技术对降解产物的形成进行了长达 18 个月的测量。两种技术都提供了可比的结果，表明环境质谱技术的直接分析为药物降解监测提供了一种可行的替代方法，具有更高的简单性、通量和可靠性（无需样品处理），并且具有可比的定量结果。在定性监测方面，EASI-MS 提供的完整质谱和完整物质允许对已知和未知（或意外）降解产物进行全面监测。
