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Keywords = cycloserine dimer

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15 pages, 2141 KiB  
Article
Determination of d-Cycloserine Impurities in Pharmaceutical Dosage Forms: Comparison of the International Pharmacopoeia HPLC–UV Method and the DOSY NMR Method
by Damjan Makuc, Živa Švab, Katerina Naumoska, Janez Plavec and Zdenko Časar
Molecules 2020, 25(7), 1684; https://doi.org/10.3390/molecules25071684 - 7 Apr 2020
Cited by 3 | Viewed by 5159
Abstract
d-cycloserine is a broad-spectrum antibiotic that is currently being used as a secondary choice in the treatment of tuberculosis. In recent years, it has become more popular, due to its effect on the nervous system. In this current study, we provide evidence [...] Read more.
d-cycloserine is a broad-spectrum antibiotic that is currently being used as a secondary choice in the treatment of tuberculosis. In recent years, it has become more popular, due to its effect on the nervous system. In this current study, we provide evidence that The International Pharmacopoeia HPLC–UV method for d-cycloserine impurity profiling is not repeatable due to the variable response of cycloserine dimer, one of d-cycloserine impurities. Therefore, we introduced the DOSY (diffusion ordered spectroscopy) NMR (nuclear magnetic resonance) technique to determine the levels of d-cycloserine impurities in pharmaceutical dosage forms. The DOSY NMR technique allowed separation of d-cycloserine, its degradation products, and key process impurities in concentrations below pharmacopoeial specification limits. The proposed DOSY NMR method allowed accurate identification and quantification of the cycloserine dimer, which was not possible through the use of the pharmacopoeial HPLC method. The current method has the potential for practical use in analytical laboratories of the pharmaceutical industry. Full article
(This article belongs to the Special Issue Drug Analysis in Pharmaceutical Development and Drug Manufacturing)
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