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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.<\/jats:p>","DOI":"10.1155\/2022\/9171836","type":"journal-article","created":{"date-parts":[[2022,9,6]],"date-time":"2022-09-06T14:05:36Z","timestamp":1662473136000},"page":"1-10","source":"Crossref","is-referenced-by-count":14,"title":["Novel Method of Analysis for the Determination of Residual Formaldehyde by High-Performance Liquid Chromatography"],"prefix":"10.1155","volume":"2022","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2480-3767","authenticated-orcid":true,"given":"Vittoria","family":"Delbono","sequence":"first","affiliation":[{"name":"Department of Chemistry, School of Natural and Computing Sciences, University of Aberdeen, Aberdeen AB24 3UE, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2463-3120","authenticated-orcid":true,"given":"Christopher P.","family":"Larch","sequence":"additional","affiliation":[{"name":"Department of Chemistry, School of Natural and Computing Sciences, University of Aberdeen, Aberdeen AB24 3UE, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6199-2080","authenticated-orcid":true,"given":"Katrina Carol","family":"Newlands","sequence":"additional","affiliation":[{"name":"Department of Chemistry, School of Natural and Computing Sciences, University of Aberdeen, Aberdeen AB24 3UE, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8201-3865","authenticated-orcid":true,"given":"Shona","family":"Rhydderch","sequence":"additional","affiliation":[{"name":"TauRx Therapeutics Ltd, 395 King Street, Aberdeen AB24 5RP, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1471-4314","authenticated-orcid":true,"given":"Thomas Craven","family":"Baddeley","sequence":"additional","affiliation":[{"name":"Department of Chemistry, School of Natural and Computing Sciences, University of Aberdeen, Aberdeen AB24 3UE, UK"},{"name":"TauRx Therapeutics Ltd, 395 King Street, Aberdeen AB24 5RP, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5261-5467","authenticated-orcid":true,"given":"John Mervyn David","family":"Storey","sequence":"additional","affiliation":[{"name":"Department of Chemistry, School of Natural and Computing Sciences, University of Aberdeen, Aberdeen AB24 3UE, UK"},{"name":"TauRx Therapeutics Ltd, 395 King Street, Aberdeen AB24 5RP, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","reference":[{"key":"1","volume-title":"Formaldehyde","author":"R. 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