{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,23]],"date-time":"2026-08-23T14:35:48Z","timestamp":1787495748786,"version":"build-2736575974"},"reference-count":27,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2022,7,18]],"date-time":"2022-07-18T00:00:00Z","timestamp":1658102400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["analyticalsciencejournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Biomedical Chromatography"],"published-print":{"date-parts":[[2022,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>To understand the role of analytics in drug development, regulatory bodies also started using the approach of Quality by Design (QbD) during analytical method developments. The present study deals with the development of the \u201cMethod Operable Design Region\u201d for assay and purity determination of risperidone in risperidone drug substance and formulations usingy UHPLC. Five different column chemistries, five different pH buffers, oven temperatures from 25 to 45\u00b0C, and different organic modifier composition, column lengths and flow rates were studied and statistically evaluated using Fusion QbD software. The final method parameters were selected by performing multivariable changes in a single run and evaluated using the Monte Carlo simulation approach. The uniqueness of this method is that it is mass compatible, a total of 10 peaks are separated within a short run time of 12.0\u00a0min and it uses a \u201cPlatforming approach\u201d, which means the use of a single method for testing the drug substance, different strengths of a drug product and different formulations. The same method can be also used for the determination of the preservative (benzoic acid) in risperidone 1\u00a0mg\/ml oral solution. The use of the QbD approach is aligned with the US Pharmacopeia\u2009&lt;1220&gt;, BP supplementary chapter 2022 and the International Conference on Harmonization Q14 guidelines for life cycle management of analytical methods.<\/jats:p>","DOI":"10.1002\/bmc.5433","type":"journal-article","created":{"date-parts":[[2022,6,27]],"date-time":"2022-06-27T20:03:36Z","timestamp":1656360216000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Application of the \u201cMethod Operable Design Region\u201d (MODR) approach for the development of a UHPLC method for the assay and purity determination of risperidone in risperidone drug substance and other formulations"],"prefix":"10.1002","volume":"36","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6858-811X","authenticated-orcid":false,"given":"Amit","family":"Pawar","sequence":"first","affiliation":[{"name":"Department of Chemistry, Sunandan Divatia School of Science NMIMS (Deemed\u2010to\u2010be) University  Mumbai Maharashtra India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2478-4383","authenticated-orcid":false,"given":"Nancy","family":"Pandita","sequence":"additional","affiliation":[{"name":"Department of Chemistry, Sunandan Divatia School of Science NMIMS (Deemed\u2010to\u2010be) University  Mumbai Maharashtra India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2022,7,18]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"crossref","unstructured":"Abdolshah M. 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