{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T03:57:29Z","timestamp":1791431849620,"version":"4.3.3"},"reference-count":13,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2025,6,26]],"date-time":"2025-06-26T00:00:00Z","timestamp":1750896000000},"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":[[2025,8]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:p>The present manuscript discusses the development and validation of a gradient reversed\u2010phase HPLC method for determining impurities in Ketorolac Tromethamine tablet dosage formulations. The analytes were separated using an Agilent Zorbax SB C8 column (250\u2009\u00d7\u20094.6\u2009mm, 5.0\u2010\u03bcm particle size). The mobile phase consisted of 0.05\u2010M ammonium phosphate buffer at pH\u20093.0 (mobile phase A) and a mixture of 40% methanol and 60% tetrahydrofuran (mobile phase B). The column temperature was maintained at 40\u00b0C, with a flow rate of 1.0\u2009mL\/min. UV detection was performed at 254\u2009nm. The method demonstrated high specificity, with a linearity range of 0.201\u20136.445\u2009\u03bcg\/mL and achieving a correlation coefficient of &gt;\u20090.999. The method exhibited high accuracy, exceeding 97%. The developed method was validated according to international ICH guidelines for specificity, linearity, precision, accuracy, and robustness. Stress studies indicated that Ketorolac Tromethamine tablets were sensitive to basic, photolytic, and oxidative stress conditions. The method was deemed suitable for quality control purposes, including impurity determination in Ketorolac Tromethamine tablets and stability\u2010indicating studies.<\/jats:p>","DOI":"10.1002\/bmc.70109","type":"journal-article","created":{"date-parts":[[2025,6,27]],"date-time":"2025-06-27T02:57:40Z","timestamp":1750993060000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Stability\u2010Indicating RP\u2010HPLC Method Development and Validation for the Quantification of Ketorolac Tromethamine\u2010Related Impurities in Tablets Solid Oral Dosage Forms"],"prefix":"10.1002","volume":"39","author":[{"given":"Prasanna\u00a0Kumar","family":"Lankalapalli","sequence":"first","affiliation":[{"name":"Visual Technologies LLC  Plano Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naveen","family":"Maddukuri","sequence":"additional","affiliation":[{"name":"Invagen Pharmaceutical Inc  Central Islip New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-2628-7574","authenticated-orcid":false,"given":"Ashok","family":"Morsu","sequence":"additional","affiliation":[{"name":"Thermo Fisher  Morrisville North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vijaykumar","family":"Chollety","sequence":"additional","affiliation":[{"name":"Ascent Pharmaceuticals Inc  Central Islip New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-6931-1512","authenticated-orcid":false,"given":"Pranitha","family":"Sambu","sequence":"additional","affiliation":[{"name":"Aurex Laboratories Pvt Ltd  Hyderabad India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-3652-9452","authenticated-orcid":false,"given":"Teja","family":"Kamireddy","sequence":"additional","affiliation":[{"name":"August Bioservices  Nashville Tennessee USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,6,26]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"crossref","unstructured":"Divadari H. T.Kamireddy R. K.Myneni.2024. \u201cStability Indicating HPLC Method Development and Validation for Quantification of Salicylic Acid Impurity in Acetaminophen Aspirin Caffeine Oral Solid Dosage Forms.\u201d 9(6): 747\u2013758.www.ijprajournal.comISSN: 2456\u20134494.","DOI":"10.35629\/4494-0906747758"},{"issue":"7","key":"e_1_2_8_3_1","first-page":"21","article-title":"Absorption Ratio Method for the Estimation of Moxifloxacin HCL & Ketorolac Tromethamine in Their Combined Dosage Form by UV\u2013Visible Spectroscopy","volume":"3","author":"Gandhi L. R.","year":"2011","journal-title":"International Journal Pharmaceutical Medicine"},{"issue":"3","key":"e_1_2_8_4_1","first-page":"77","article-title":"Development and Validation of Stability Indicating HPTLC Method for Determination of Ofloxacin and Ketorolac Tromethamine in Combination","volume":"2","author":"Gandhi S. P.","year":"2011","journal-title":"Journal of Advanced Scientific Research"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.microc.2023.109835"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/bmc.6048"},{"key":"e_1_2_8_7_1","unstructured":"Maddukuri N. A.Morsu T.Kamireddy P. K.Lankalapalli P.Sambu andV.Chollety.2025. \u201cStability\u2010Indicating RP\u2010HPLC Method Development and Validation for the Quantification of Ketorolac Tromethamine Tablets in Solid Oral Dosage Forms Chemistry Research Journal.\u201d10(1):21\u201328."},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/bmc.6088"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/bmc.5626"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/bmc.5944"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.arabjc.2012.12.031"},{"key":"e_1_2_8_12_1","doi-asserted-by":"crossref","unstructured":"Teja K. P.Sambu P. K.Lankalapalli R. K.Myneni andH.Divadari.2024. \u201cStability\u2010Indicating RP\u2010HPLC Method Development and Validation for the Quantification of Amlodipine Besylate and Valsartan Tablets in Solid Oral Dosage Form.\u201d Publication Date: Sep 26 2024.https:\/\/doi.org\/10.1002\/bmc.6017.","DOI":"10.1002\/bmc.70103"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/bmc.5800"},{"key":"e_1_2_8_14_1","doi-asserted-by":"crossref","unstructured":"Vrushali S. T. M. N.Deodhar andV.Prakya.2016. \u201cLC and LC\u2013MS Study for Simultaneous Determination of Tramadol Hydrochloride and Ketorolac Tromethamine in Bulk and Formulation With Their Major Degradation Products.\u201d Accepted February 1 2016.https:\/\/doi.org\/10.1016\/j.bfopcu.2016.02.002.","DOI":"10.1016\/j.bfopcu.2016.02.002"}],"container-title":["Biomedical Chromatography"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/bmc.70109","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,9]],"date-time":"2025-10-09T19:39:14Z","timestamp":1760038754000},"score":1,"resource":{"primary":{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/10.1002\/bmc.70109"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,6,26]]},"references-count":13,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2025,8]]}},"alternative-id":["10.1002\/bmc.70109"],"URL":"https:\/\/doi.org\/10.1002\/bmc.70109","archive":["Portico"],"relation":{},"ISSN":["0269-3879","1099-0801"],"issn-type":[{"value":"0269-3879","type":"print"},{"value":"1099-0801","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,6,26]]},"assertion":[{"value":"2025-03-28","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-05-05","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-06-26","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70109"}}