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Direct monitoring of drug degradation by easy ambient sonic-spray ionization mass spectrometry: the case of enalapril

✍ Scribed by Phellipe H. Amaral; Raquel Fernandes; Marcos N. Eberlin; Nelci F. Höehr

Book ID
102382038
Publisher
John Wiley and Sons
Year
2011
Tongue
English
Weight
307 KB
Volume
46
Category
Article
ISSN
1076-5174

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✦ Synopsis

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.

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