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Journal of Analytical Methods in Chemistry
Volume 2018, Article ID 4526396, 8 pages
https://doi.org/10.1155/2018/4526396
Research Article

A Robust Static Headspace GC-FID Method to Detect and Quantify Formaldehyde Impurity in Pharmaceutical Excipients

1Department of Pharmaceutical Chemistry and Quality Control, Faculty of Pharmacy, Damascus University, Damascus, Syria
2Department of Chemistry, Faculty of Science, Damascus University, Damascus, Syria

Correspondence should be addressed to Bashir Daoud Agha Dit Daoudy; moc.liamtoh@yduoad-rihsab

Received 20 June 2017; Accepted 17 October 2017; Published 4 March 2018

Academic Editor: Krishna K. Verma

Copyright © 2018 Bashir Daoud Agha Dit Daoudy et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Formaldehyde is a highly reactive impurity that can be found in many pharmaceutical excipients. Trace levels of this impurity may affect drug product stability, safety, efficacy, and performance. A static headspace gas chromatographic method was developed and validated to determine formaldehyde in pharmaceutical excipients after an effective derivatization procedure using acidified ethanol. Diethoxymethane, the derivative of formaldehyde, was then directly analyzed by GC-FID. Despite the simplicity of the developed method, however, it is characterized by its specificity, accuracy, and precision. The limits of detection and quantification of formaldehyde in the samples were of 2.44 and 8.12 µg/g, respectively. This method is characterized by using simple and economic GC-FID technique instead of MS detection, and it is successfully used to analyze formaldehyde in commonly used pharmaceutical excipients.