{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T04:45:34Z","timestamp":1790052334383,"version":"4.0.1"},"reference-count":35,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2025,10,30]],"date-time":"2025-10-30T00:00:00Z","timestamp":1761782400000},"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":[[2025,12]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    A stable reversed\u2010phase high\u2010performance liquid chromatography method was developed and validated to quantify related substances in nitrofurantoin capsule formulations. Based on response surface methodology and experimental design, the Box\u2013Behnken design technique improved method performance and dependability. The mobile phase\u2010A was formulated by mixing 0.2% formic acid solution and tetrahydrofuran in the ratio of 95:5% (\n                    <jats:italic>v<\/jats:italic>\n                    \/\n                    <jats:italic>v<\/jats:italic>\n                    ), and the mobile phase\u2010B was formulated by mixing methanol, acetonitrile, and tetrahydrofuran in the ratio of 50:40:10 (\n                    <jats:italic>v<\/jats:italic>\n                    \/\n                    <jats:italic>v<\/jats:italic>\n                    \/\n                    <jats:italic>v<\/jats:italic>\n                    ) using gradient elution with a flow rate of 0.8\u2009mL\/min. Chromatographic separation was achieved using an Inertsil ODS\u20103 C18 column (250\u2009mm\u2009\u00d7\u20094.6\u2009mm, 5\u2009\u03bcm), with detection at 285\u2009nm and column temperature maintained at 30\u00b0C. The method was validated according to ICH and USP &lt;1225&gt; guidelines. This is demonstrated by high\u2010level accuracy, covering an entire range from 92% to 111%. Precision (resistance \u2264\u20091.0%) and linearity (\n                    <jats:italic>R<\/jats:italic>\n                    <jats:sup>2<\/jats:sup>\n                    \u2009&gt;\u20090.999). Box\u2013Behnken design\u2013based RP\u2010HPLC technique for nitrofurantoin formulations is significant because it uses a systematic, statistically optimized approach to method development to assure robustness, accuracy, and dependability. This work provides a proven stability\u2010indicating approach for routine quality control and regulatory compliance to address safety concerns about nitrofurantoin degradation products and impurities.\n                  <\/jats:p>","DOI":"10.1002\/bmc.70247","type":"journal-article","created":{"date-parts":[[2025,10,30]],"date-time":"2025-10-30T14:31:16Z","timestamp":1761834676000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Box\u2013Behnken Design\u2013Based Development and Validation of RP\u2010HPLC Method for Determination of Related Substances in Nitrofurantoin Formulations"],"prefix":"10.1002","volume":"39","author":[{"ORCID":"https:\/\/orcid.org\/0009-0009-5447-3413","authenticated-orcid":false,"given":"Prasanth","family":"Katakam","sequence":"first","affiliation":[{"name":"Department of Chemistry Vignan's Foundation for Science Technology &amp; Research  Guntur Andhra Pradesh India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mahesh\u00a0J.","family":"Wadgeri","sequence":"additional","affiliation":[{"name":"Analytical Research and Development Rising Pharma Specialities Private Limited  Hyderabad Telangana India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3859-4364","authenticated-orcid":false,"given":"Bharat\u00a0Kumar","family":"Tripuramallu","sequence":"additional","affiliation":[{"name":"Department of Chemistry Vignan's Foundation for Science Technology &amp; Research  Guntur Andhra Pradesh India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9446-5244","authenticated-orcid":false,"given":"Vijay\u00a0Kumar","family":"Chollety","sequence":"additional","affiliation":[{"name":"Ascent Pharmaceuticals Inc  Central Islip New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,10,30]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.3821\/1913\u2010701X\u2010142.5.248"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/bmc.6062"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/jps.2600630441"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/bmc.70101"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/sscp.70048"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.5281\/zenodo.573530"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1080\/00032718708067993"},{"key":"e_1_2_8_9_1","unstructured":"Daily Med \u2013 Macrodantin\u2010nitrofurantoin macrocrystals capsule.2024.https:\/\/dailymed.nlm.nih.gov\/dailymed\/drugInfo.cfm?setid=89d8696b\u2010f9ce\u20109691\u20106222\u20108416ca143bba."},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1080\/10826079408013364"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/bmc.6001"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/bmc.70129"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003495-200161030-00004"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaubas.2017.03.005"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/bmc.70006"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1093\/clinchem\/16.4.335"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dkv147"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dkz095"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.21608\/rpbs.2023.169403.1181"},{"key":"e_1_2_8_20_1","unstructured":"ICH.2005. \u201cValidation of Analytical Procedures: Text and Methodology Q2 (R1) Current Step 4 Version Dated 1996 and 2005.\u201dhttps:\/\/database.ich.org\/sites\/default\/files\/Q2%28R1%29%20Guideline.pdf."},{"key":"e_1_2_8_21_1","unstructured":"ICH.2023. \u201cValidation of Analytical Procedures: Text and Methodology Q2 (R2) Final Version Adopted on 01 November 2023\u201d."},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1002\/bmc.70064"},{"key":"e_1_2_8_23_1","unstructured":"Karajgi S. andS.Mali.2017. \u201cUV Spectrophotometric Area Under Curve Method for the Determination of Nitrofurantoin in Tablet Formulations.\u201dhttps:\/\/doi.org\/10.24327\/ijrsr.2018.0901.1439."},{"key":"e_1_2_8_24_1","doi-asserted-by":"publisher","DOI":"10.1002\/bmc.70007"},{"key":"e_1_2_8_25_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.pharma.2025.04.006"},{"key":"e_1_2_8_26_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vetmic.2011.03.009"},{"key":"e_1_2_8_27_1","doi-asserted-by":"publisher","DOI":"10.1002\/bmc.5687"},{"key":"e_1_2_8_28_1","doi-asserted-by":"publisher","DOI":"10.1007\/S13738\u2010021\u201002388\u20105"},{"key":"e_1_2_8_29_1","doi-asserted-by":"publisher","DOI":"10.1016\/J.CHROMA.2022.463380"},{"key":"e_1_2_8_30_1","doi-asserted-by":"publisher","DOI":"10.1002\/sscp.70031"},{"key":"e_1_2_8_31_1","unstructured":"Nitrofurantoin: Side Effects Dosage Uses and More.2024.https:\/\/www.medicalnewstoday.com\/articles\/nitrofurantoin\u2010oral\u2010capsule#about."},{"key":"e_1_2_8_32_1","doi-asserted-by":"publisher","DOI":"10.2478\/acph\u20102013\u20100012"},{"issue":"2","key":"e_1_2_8_33_1","first-page":"196","article-title":"Simple, Rapid and Sensitive Method for Determination of Nitrofurantoin in Human Plasma by Using Liquid Chromatography\/Tandem Mass Spectrometry","volume":"6","author":"Patil R. 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