Characterization of two excipient interaction degradation products in oseltamivir phosphate powder for oral suspension by MS and NMR
Oseltamivir phosphate is widely used to treat and prevent influenza, and is available in the form of capsules, powder for oral suspension, pediatric solutions, and granules. Because of the amino group, oseltamivir is easy to react with the excipients of the formulation to generate drug‐excipient int...
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Published in | Journal of mass spectrometry. Vol. 57; no. 12; pp. e4899 - n/a |
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Main Authors | , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
England
Wiley Subscription Services, Inc
01.12.2022
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Subjects | |
Online Access | Get full text |
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Summary: | Oseltamivir phosphate is widely used to treat and prevent influenza, and is available in the form of capsules, powder for oral suspension, pediatric solutions, and granules. Because of the amino group, oseltamivir is easy to react with the excipients of the formulation to generate drug‐excipient interaction impurities. In this research, two degradation products in a commercial oseltamivir phosphate powder for oral suspension due to interaction between API and citrate were investigated. They were characterized to be 3‐((−6‐acetamido‐3‐(ethoxycarbonyl)‐5‐(pentan‐3‐yloxy)cyclohex‐3‐en‐1‐yl)carbamoyl)‐3‐hydroxypentanedioic acid and 2‐(2‐((−6‐acetamido‐3‐(ethoxycarbonyl)‐5‐(pentan‐3‐yloxy)cyclohex‐3‐en‐1‐yl)amino)‐2‐oxoethyl)‐2‐hydroxysuccinic acid by MS and NMR, respectively. Furthermore, the formation mechanisms of these impurities were verified, and the method of analysis of covariance was used to assess the rate of impurities' degradation.
Highlights
Two excipient interaction degradation products in commercial oseltamivir phosphate powder for oral suspension were studied and elucidated in detail via LC–MS/MS and NMR.
The incompatibility risk of pH conditioners such as citrate and citric acid with formulations that contain an amino group was disclosed in this article.
Analysis of covariance was demonstrated to assess the impact of various formulations and preparation techniques on the rate of impurity degradation. |
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Bibliography: | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 |
ISSN: | 1076-5174 1096-9888 |
DOI: | 10.1002/jms.4899 |