A simple and easy non‐derivatization gas chromatography‐mass spectrometry method for simultaneous quantification of valproic acid, gabapentin, pregabalin, and vigabatrin in human plasma

Immunoassays are currently not available in commercial kits for the quantification of valproic acid, vigabatrin, pregabalin, and gabapentin, which also cannot suffer the limitations of interferences of substances with similar structures. Chromatography is a good alternative to immunoassay. In this s...

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Published in:	Journal of separation science Vol. 46; no. 2; pp. e2200622 - n/a
Main Authors:	Jin, Peng, You, Yu‐xin, Zhao, Lin‐lin, Zhao, Yan‐lin, Zheng, Xiao‐xiao, Du, Yan, Tang, Dao‐quan
Format:	Journal Article
Language:	English
Published:	Germany Wiley Subscription Services, Inc 01.01.2023
Subjects:	Acidification Amines - analysis Anticonvulsants antiepileptic drugs Benzoic acid Blood plasma chemical species Chromatography Correlation coefficients Cyclohexanecarboxylic Acids - analysis Cyclohexanecarboxylic Acids - chemistry Epilepsy Gabapentin - analysis gamma-Aminobutyric Acid Gas chromatography gas chromatography-mass spectrometry Gas Chromatography-Mass Spectrometry - methods human plasma Humans Hydrochloric acid Immunoassay immunoassays Linearity Mass spectrometry non‐derivatization Plasma Pregabalin - analysis Scientific imaging separation Spectroscopy standard deviation therapeutic drug monitoring therapeutics valproic acid Valproic Acid - analysis Vigabatrin - analysis antiepileptic drugs gas chromatography-mass spectrometry non-derivatization human plasma therapeutic drug monitoring
ISSN:	1615-9306, 1615-9314, 1615-9314
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Abstract	Immunoassays are currently not available in commercial kits for the quantification of valproic acid, vigabatrin, pregabalin, and gabapentin, which also cannot suffer the limitations of interferences of substances with similar structures. Chromatography is a good alternative to immunoassay. In this study, a simple and robust non‐derivatization gas chromatography‐mass spectrometry method for simultaneous determination of the above four drugs in human plasma was developed and validated for therapeutic drug monitoring purposes. This method employed benzoic acid as the internal standard with hydrochloric acid for plasma acidification and ACN for precipitate protein. The supernatant was directly injected into gas chromatography‐mass spectrometry for analysis. Good linearity was obtained with linear correlation coefficients of the four analytes of 0.9988–0.9996. Extraction recoveries of valproic acid, vigabatrin, pregabalin, and gabapentin were respectively in the ranges of 91.3%–94.5%, 90.0%–90.9%, 90.0%–92.1%, and 88.0%–92.2% with the relative standard deviation values less than 12.6%. Intra‐ and inter‐batch precision and accuracy, and stability assays were all acceptable. Taken together, the novel method developed in this study provided easy plasma pretreatment, good extraction yield, and high chromatographic resolution, which has been successfully validated through the quantification of valproic acid in the plasma of 46 patients with epilepsy.
AbstractList	Immunoassays are currently not available in commercial kits for the quantification of valproic acid, vigabatrin, pregabalin, and gabapentin, which also cannot suffer the limitations of interferences of substances with similar structures. Chromatography is a good alternative to immunoassay. In this study, a simple and robust non‐derivatization gas chromatography‐mass spectrometry method for simultaneous determination of the above four drugs in human plasma was developed and validated for therapeutic drug monitoring purposes. This method employed benzoic acid as the internal standard with hydrochloric acid for plasma acidification and ACN for precipitate protein. The supernatant was directly injected into gas chromatography‐mass spectrometry for analysis. Good linearity was obtained with linear correlation coefficients of the four analytes of 0.9988–0.9996. Extraction recoveries of valproic acid, vigabatrin, pregabalin, and gabapentin were respectively in the ranges of 91.3%–94.5%, 90.0%–90.9%, 90.0%–92.1%, and 88.0%–92.2% with the relative standard deviation values less than 12.6%. Intra‐ and inter‐batch precision and accuracy, and stability assays were all acceptable. Taken together, the novel method developed in this study provided easy plasma pretreatment, good extraction yield, and high chromatographic resolution, which has been successfully validated through the quantification of valproic acid in the plasma of 46 patients with epilepsy. Immunoassays are currently not available in commercial kits for the quantification of valproic acid, vigabatrin, pregabalin, and gabapentin, which also cannot suffer the limitations of interferences of substances with similar structures. Chromatography is a good alternative to immunoassay. In this study, a simple and robust non-derivatization gas chromatography-mass spectrometry method for simultaneous determination of the above four drugs in human plasma was developed and validated for therapeutic drug monitoring purposes. This method employed benzoic acid as the internal standard with hydrochloric acid for plasma acidification and ACN for precipitate protein. The supernatant was directly injected into gas chromatography-mass spectrometry for analysis. Good linearity was obtained with linear correlation coefficients of the four analytes of 0.9988-0.9996. Extraction recoveries of valproic acid, vigabatrin, pregabalin, and gabapentin were respectively in the ranges of 91.3%-94.5%, 90.0%-90.9%, 90.0%-92.1%, and 88.0%-92.2% with the relative standard deviation values less than 12.6%. Intra- and inter-batch precision and accuracy, and stability assays were all acceptable. Taken together, the novel method developed in this study provided easy plasma pretreatment, good extraction yield, and high chromatographic resolution, which has been successfully validated through the quantification of valproic acid in the plasma of 46 patients with epilepsy.Immunoassays are currently not available in commercial kits for the quantification of valproic acid, vigabatrin, pregabalin, and gabapentin, which also cannot suffer the limitations of interferences of substances with similar structures. Chromatography is a good alternative to immunoassay. In this study, a simple and robust non-derivatization gas chromatography-mass spectrometry method for simultaneous determination of the above four drugs in human plasma was developed and validated for therapeutic drug monitoring purposes. This method employed benzoic acid as the internal standard with hydrochloric acid for plasma acidification and ACN for precipitate protein. The supernatant was directly injected into gas chromatography-mass spectrometry for analysis. Good linearity was obtained with linear correlation coefficients of the four analytes of 0.9988-0.9996. Extraction recoveries of valproic acid, vigabatrin, pregabalin, and gabapentin were respectively in the ranges of 91.3%-94.5%, 90.0%-90.9%, 90.0%-92.1%, and 88.0%-92.2% with the relative standard deviation values less than 12.6%. Intra- and inter-batch precision and accuracy, and stability assays were all acceptable. Taken together, the novel method developed in this study provided easy plasma pretreatment, good extraction yield, and high chromatographic resolution, which has been successfully validated through the quantification of valproic acid in the plasma of 46 patients with epilepsy.
Author	Zhao, Yan‐lin Tang, Dao‐quan Du, Yan Zheng, Xiao‐xiao You, Yu‐xin Jin, Peng Zhao, Lin‐lin
Author_xml	– sequence: 1 givenname: Peng surname: Jin fullname: Jin, Peng organization: Xuzhou Medical University – sequence: 2 givenname: Yu‐xin surname: You fullname: You, Yu‐xin organization: Xuzhou Medical University – sequence: 3 givenname: Lin‐lin surname: Zhao fullname: Zhao, Lin‐lin organization: Xuzhou Medical University – sequence: 4 givenname: Yan‐lin surname: Zhao fullname: Zhao, Yan‐lin organization: Suining Branch of the Hospital Affiliated to Xuzhou Medical University – sequence: 5 givenname: Xiao‐xiao surname: Zheng fullname: Zheng, Xiao‐xiao organization: Xuzhou Municipal Hospital Affiliated to Xuzhou Medical University – sequence: 6 givenname: Yan orcidid: 0000-0003-3506-6993 surname: Du fullname: Du, Yan organization: Xuzhou Medical University – sequence: 7 givenname: Dao‐quan orcidid: 0000-0002-5443-4619 surname: Tang fullname: Tang, Dao‐quan email: tangdq@xzhmu.edu.cn, tdq993@hotmail.com organization: Xuzhou Medical University
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Snippet	Immunoassays are currently not available in commercial kits for the quantification of valproic acid, vigabatrin, pregabalin, and gabapentin, which also cannot...
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SubjectTerms	Acidification Amines - analysis Anticonvulsants antiepileptic drugs Benzoic acid Blood plasma chemical species Chromatography Correlation coefficients Cyclohexanecarboxylic Acids - analysis Cyclohexanecarboxylic Acids - chemistry Epilepsy Gabapentin - analysis gamma-Aminobutyric Acid Gas chromatography gas chromatography-mass spectrometry Gas Chromatography-Mass Spectrometry - methods human plasma Humans Hydrochloric acid Immunoassay immunoassays Linearity Mass spectrometry non‐derivatization Plasma Pregabalin - analysis Scientific imaging separation Spectroscopy standard deviation therapeutic drug monitoring therapeutics valproic acid Valproic Acid - analysis Vigabatrin - analysis
Title	A simple and easy non‐derivatization gas chromatography‐mass spectrometry method for simultaneous quantification of valproic acid, gabapentin, pregabalin, and vigabatrin in human plasma
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