Novel Method of Analysis for the Determination of Residual Formaldehyde by High-Performance Liquid Chromatography
Formaldehyde is commonly used as an alkylating agent in the pharmaceutical industry. Consequently, its residual level in drug substances and/or their intermediates needs to be accurately quantified. Formaldehyde is a small, volatile molecule with a weak chromophore (the carbonyl group), and its dire...
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| Format: | Article |
| Language: | English |
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Wiley
2022-01-01
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| Series: | International Journal of Analytical Chemistry |
| Online Access: | http://dx.doi.org/10.1155/2022/9171836 |
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| author | Vittoria Delbono Christopher P. Larch Katrina Carol Newlands Shona Rhydderch Thomas Craven Baddeley John Mervyn David Storey |
| author_facet | Vittoria Delbono Christopher P. Larch Katrina Carol Newlands Shona Rhydderch Thomas Craven Baddeley John Mervyn David Storey |
| author_sort | Vittoria Delbono |
| collection | DOAJ |
| description | Formaldehyde is commonly used as an alkylating agent in the pharmaceutical industry. Consequently, its residual level in drug substances and/or their intermediates needs to be accurately quantified. Formaldehyde is a small, volatile molecule with a weak chromophore (the carbonyl group), and its direct analysis by GC-FID and HPLC-UV is difficult. For these reasons, the majority of papers found in the literature are based upon a derivatisation process (most commonly using the desensitised explosive 2,4-dinitrophenylhydrazine) prior to the analysis of formaldehyde. A novel high-performance liquid chromatography (HPLC) method with UV detection for its quantification in a pharmaceutical is described in this paper. The method proposed herein is based upon a derivatisation reaction between formaldehyde and 4-methylbenzenesulfonohydrazide (MBSH) before analysis by HPLC-UV. Selectivity, linearity, limit of quantification, accuracy, repeatability, intermediate precision, and solution stability were successfully assessed as per ICH guideline Q2(R1), and the method has also been validated in a good manufacturing practice (GMP) laboratory in the UK. |
| format | Article |
| id | doaj-art-f1d4c5688d8740b1aab924145d9e0921 |
| institution | Kabale University |
| issn | 1687-8779 |
| language | English |
| publishDate | 2022-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | International Journal of Analytical Chemistry |
| spelling | doaj-art-f1d4c5688d8740b1aab924145d9e09212025-02-03T05:49:20ZengWileyInternational Journal of Analytical Chemistry1687-87792022-01-01202210.1155/2022/9171836Novel Method of Analysis for the Determination of Residual Formaldehyde by High-Performance Liquid ChromatographyVittoria Delbono0Christopher P. Larch1Katrina Carol Newlands2Shona Rhydderch3Thomas Craven Baddeley4John Mervyn David Storey5Department of ChemistryDepartment of ChemistryDepartment of ChemistryTauRx Therapeutics LtdDepartment of ChemistryDepartment of ChemistryFormaldehyde is commonly used as an alkylating agent in the pharmaceutical industry. Consequently, its residual level in drug substances and/or their intermediates needs to be accurately quantified. Formaldehyde is a small, volatile molecule with a weak chromophore (the carbonyl group), and its direct analysis by GC-FID and HPLC-UV is difficult. For these reasons, the majority of papers found in the literature are based upon a derivatisation process (most commonly using the desensitised explosive 2,4-dinitrophenylhydrazine) prior to the analysis of formaldehyde. A novel high-performance liquid chromatography (HPLC) method with UV detection for its quantification in a pharmaceutical is described in this paper. The method proposed herein is based upon a derivatisation reaction between formaldehyde and 4-methylbenzenesulfonohydrazide (MBSH) before analysis by HPLC-UV. Selectivity, linearity, limit of quantification, accuracy, repeatability, intermediate precision, and solution stability were successfully assessed as per ICH guideline Q2(R1), and the method has also been validated in a good manufacturing practice (GMP) laboratory in the UK.http://dx.doi.org/10.1155/2022/9171836 |
| spellingShingle | Vittoria Delbono Christopher P. Larch Katrina Carol Newlands Shona Rhydderch Thomas Craven Baddeley John Mervyn David Storey Novel Method of Analysis for the Determination of Residual Formaldehyde by High-Performance Liquid Chromatography International Journal of Analytical Chemistry |
| title | Novel Method of Analysis for the Determination of Residual Formaldehyde by High-Performance Liquid Chromatography |
| title_full | Novel Method of Analysis for the Determination of Residual Formaldehyde by High-Performance Liquid Chromatography |
| title_fullStr | Novel Method of Analysis for the Determination of Residual Formaldehyde by High-Performance Liquid Chromatography |
| title_full_unstemmed | Novel Method of Analysis for the Determination of Residual Formaldehyde by High-Performance Liquid Chromatography |
| title_short | Novel Method of Analysis for the Determination of Residual Formaldehyde by High-Performance Liquid Chromatography |
| title_sort | novel method of analysis for the determination of residual formaldehyde by high performance liquid chromatography |
| url | http://dx.doi.org/10.1155/2022/9171836 |
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