{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,12]],"date-time":"2026-05-12T20:25:17Z","timestamp":1778617517277,"version":"3.51.4"},"reference-count":17,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2025,3,12]],"date-time":"2025-03-12T00:00:00Z","timestamp":1741737600000},"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":[[2025,4]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:p>A quality by design (QbD)\u2010based high\u2010resolution, stability\u2010indicating high\u2010performance liquid chromatography (HPLC) method was developed for determining impurities in loperamide hydrochloride (LPH) tablet dosage forms. Using this method, eight known impurities were qualified, and three degradants were quantified with excellent peak resolution. Mobile Phase\u2010A consisted of 0.05\u2010M tetrabutylammonium hydrogen phosphate buffer and acetonitrile (80:20, v\/v), while Mobile Phase\u2010B contained the same buffer and acetonitrile (20:80, v\/v). The gradient program was as follows: 0\u2009min, MP\u2010A 95%, MP\u2010B 5%; 15\u2009min, MP\u2010A 30%, MP\u2010B 70%; 17\u2009min, MP\u2010A 30%, MP\u2010B 70%; 19\u2009min, MP\u2010A 95%, MP\u2010B 5%; and 24\u2009min, MP\u2010A 95%, MP\u2010B 5%. Chromatographic separation was performed using a column zodiac C18 (100\u2009mm\u2009\u00d7\u20094.6\u2009mm, 3.0\u2009\u03bcm) with a flow rate of 1.5\u2009mL\/min, detection at 220\u2009nm, an injection volume of 10\u2009\u03bcL, and a column temperature of 35\u00b0C.<\/jats:p><jats:p>Stress studies revealed LPH's sensitivity to acidic, oxidative, and thermal conditions. Under all forced degradation conditions, the purity angle was found to be less than the purity threshold, demonstrating the robustness of the method. Validation confirmed its suitability for quality analysis and stability studies in routine manufacturing processes.<\/jats:p>","DOI":"10.1002\/bmc.70027","type":"journal-article","created":{"date-parts":[[2025,3,12]],"date-time":"2025-03-12T06:25:25Z","timestamp":1741760725000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Stability\u2010Indicating RP\u2010HPLC Method Development and Validation for Determination of Impurities in Loperamide Hydrochloride Capsules Dosage Form"],"prefix":"10.1002","volume":"39","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3928-7454","authenticated-orcid":false,"given":"Sreenivas","family":"Pippalla","sequence":"first","affiliation":[{"name":"Sikkim Professional University Gangtok  Gangtok Sikkim India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-6939-0261","authenticated-orcid":false,"given":"Vaishnavi","family":"Chintala","sequence":"additional","affiliation":[{"name":"Cambrex High Point  High Point North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,3,12]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-3565(24)38161-3"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.35629\/4494\u20100906747758"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0731\u20107085(99)00239\u20133"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jopr.2013.07.031"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1452\u20103981(23)15812\u20103"},{"key":"e_1_2_7_7_1","unstructured":"ICH.2005. \u201cValidation of Analytical Procedures.\u201d Text and Methodolgy Q2(R1)."},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.microc.2023.109835"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1021\/acsomega.3c04589"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/bmc.6017"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.5055\/jom.2013.0172"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/bmc.6048"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0090-9556(25)06545-6"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/bmc.5626"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.2298\/HEMIND0901039S"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.4236\/ajac.2022.1312036"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/bmc.5944"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1002\/bmc.5800"}],"container-title":["Biomedical Chromatography"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/bmc.70027","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T00:06:24Z","timestamp":1760054784000},"score":1,"resource":{"primary":{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/10.1002\/bmc.70027"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,3,12]]},"references-count":17,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2025,4]]}},"alternative-id":["10.1002\/bmc.70027"],"URL":"https:\/\/doi.org\/10.1002\/bmc.70027","archive":["Portico"],"relation":{},"ISSN":["0269-3879","1099-0801"],"issn-type":[{"value":"0269-3879","type":"print"},{"value":"1099-0801","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,3,12]]},"assertion":[{"value":"2024-12-20","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-02-03","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-03-12","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70027"}}