Validated HPLC Methodology for Pregabalin Quantification in Human Urine Using 1-Fluoro-2,4-dinitrobenzene Derivatization

Pregabalin (PGB) is a synthetic drug used for the treatment of central nervous system disorders and neuropathic pain. PGB is metabolized to N-Methyl pregabalin while the rest is excreted virtually unchanged in the urine. Numerous analytical techniques for measuring pregabalin have been documented....

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Main Authors: Mohamedsaid mostafa Said Mostafa, Hosam Abdel Fattah Mohamed Elshebiny, Olfat Elsayed Mostafa, Shimaa Talaat Elsayed, Mohamed Abdelizm Abdelaziz
Format: Article
Language:English
Published: Universidade Federal do Rio Grande do Sul 2024-12-01
Series:Drug Analytical Research
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Online Access:https://seer.ufrgs.br/rita/citati/index.php/dar/article/view/143059
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author Mohamedsaid mostafa Said Mostafa
Hosam Abdel Fattah Mohamed Elshebiny
Olfat Elsayed Mostafa
Shimaa Talaat Elsayed
Mohamed Abdelizm Abdelaziz
author_facet Mohamedsaid mostafa Said Mostafa
Hosam Abdel Fattah Mohamed Elshebiny
Olfat Elsayed Mostafa
Shimaa Talaat Elsayed
Mohamed Abdelizm Abdelaziz
author_sort Mohamedsaid mostafa Said Mostafa
collection DOAJ
description Pregabalin (PGB) is a synthetic drug used for the treatment of central nervous system disorders and neuropathic pain. PGB is metabolized to N-Methyl pregabalin while the rest is excreted virtually unchanged in the urine. Numerous analytical techniques for measuring pregabalin have been documented. This study aimed to validate a simple, sensitive, and accurate method for PGB quantification in human urine using the HPLC technique with 1-Fluoro-2, 4-dinitrobenzene used as a derivatizing agent. One hundred and twenty urine samples were analyzed by a reversed-phase (C18) column and a mixture of acetonitrile and 50 mM KH2PO4 (pH 2.5) (60:40, v/v) as mobile phase and the flow rate was 1 ml/min and the UV detector wavelength was set to 360nm. The procedure was linear within the 10-1000 μg/ml range of PGB in urine (r > 0.99). Intraday and interday RSD precision values fell between 2.8% and 5.9%. 2.5 and 1.5 μg/ml, respectively, were determined to be the method's limits of quantification and detection. The recovery (90.8%) and statistical characteristics show that the suggested method has excellent accuracy and precision. The method is accurate, precise, reproducible, and specific, and it can be applied to regular examinations of pregabalin in urine samples.
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spelling doaj-art-ef6e0856cf444a6896748afb042f6f522025-01-07T18:21:25ZengUniversidade Federal do Rio Grande do SulDrug Analytical Research2527-26162024-12-018210.22456/2527-2616.143059Validated HPLC Methodology for Pregabalin Quantification in Human Urine Using 1-Fluoro-2,4-dinitrobenzene DerivatizationMohamedsaid mostafa Said Mostafa0Hosam Abdel Fattah Mohamed Elshebiny1Olfat Elsayed Mostafa2Shimaa Talaat Elsayed3Mohamed Abdelizm Abdelaziz4Poison Control Center, Ain Shams University Hospitals, 11517, Cairo, EgyptPoison Control Center, Ain Shams University Hospitals, 11517, Cairo, EgyptPoison Control Center, Ain Shams University Hospitals, 11517, Cairo, EgyptPoison Control Center, Ain Shams University Hospitals, 11517, Cairo, EgyptPoison control center, Ain Shams University Hospitals, Cairo, Egypt Pregabalin (PGB) is a synthetic drug used for the treatment of central nervous system disorders and neuropathic pain. PGB is metabolized to N-Methyl pregabalin while the rest is excreted virtually unchanged in the urine. Numerous analytical techniques for measuring pregabalin have been documented. This study aimed to validate a simple, sensitive, and accurate method for PGB quantification in human urine using the HPLC technique with 1-Fluoro-2, 4-dinitrobenzene used as a derivatizing agent. One hundred and twenty urine samples were analyzed by a reversed-phase (C18) column and a mixture of acetonitrile and 50 mM KH2PO4 (pH 2.5) (60:40, v/v) as mobile phase and the flow rate was 1 ml/min and the UV detector wavelength was set to 360nm. The procedure was linear within the 10-1000 μg/ml range of PGB in urine (r > 0.99). Intraday and interday RSD precision values fell between 2.8% and 5.9%. 2.5 and 1.5 μg/ml, respectively, were determined to be the method's limits of quantification and detection. The recovery (90.8%) and statistical characteristics show that the suggested method has excellent accuracy and precision. The method is accurate, precise, reproducible, and specific, and it can be applied to regular examinations of pregabalin in urine samples. https://seer.ufrgs.br/rita/citati/index.php/dar/article/view/143059Pregabalin1-Fluoro-2,4-dinitrobenzenederivatizationvalidationHPLC analysis
spellingShingle Mohamedsaid mostafa Said Mostafa
Hosam Abdel Fattah Mohamed Elshebiny
Olfat Elsayed Mostafa
Shimaa Talaat Elsayed
Mohamed Abdelizm Abdelaziz
Validated HPLC Methodology for Pregabalin Quantification in Human Urine Using 1-Fluoro-2,4-dinitrobenzene Derivatization
Drug Analytical Research
Pregabalin
1-Fluoro-2,4-dinitrobenzene
derivatization
validation
HPLC analysis
title Validated HPLC Methodology for Pregabalin Quantification in Human Urine Using 1-Fluoro-2,4-dinitrobenzene Derivatization
title_full Validated HPLC Methodology for Pregabalin Quantification in Human Urine Using 1-Fluoro-2,4-dinitrobenzene Derivatization
title_fullStr Validated HPLC Methodology for Pregabalin Quantification in Human Urine Using 1-Fluoro-2,4-dinitrobenzene Derivatization
title_full_unstemmed Validated HPLC Methodology for Pregabalin Quantification in Human Urine Using 1-Fluoro-2,4-dinitrobenzene Derivatization
title_short Validated HPLC Methodology for Pregabalin Quantification in Human Urine Using 1-Fluoro-2,4-dinitrobenzene Derivatization
title_sort validated hplc methodology for pregabalin quantification in human urine using 1 fluoro 2 4 dinitrobenzene derivatization
topic Pregabalin
1-Fluoro-2,4-dinitrobenzene
derivatization
validation
HPLC analysis
url https://seer.ufrgs.br/rita/citati/index.php/dar/article/view/143059
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