{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T12:06:09Z","timestamp":1792065969769,"version":"4.4.0"},"reference-count":26,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2026,3,22]],"date-time":"2026-03-22T00:00:00Z","timestamp":1774137600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,3,22]],"date-time":"2026-03-22T00:00:00Z","timestamp":1774137600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["analyticalsciencejournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Biomedical Chromatography"],"published-print":{"date-parts":[[2026,5]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    A precise, robust, and stability\u2010indicating liquid chromatographic (LC) method coupled with a photodiode array (PDA) detector was developed and validated for the quantitative estimation of rifapentine, an essential therapeutic agent for both active and latent tuberculosis (TB). The chromatographic separation was achieved on a YMC Pack C18 column (250\u2009\u00d7\u20094.6\u2009mm, 5\u2009\u03bcm) using a gradient elution with Solvent A composed of phosphate buffer (pH\u20096.3) and acetonitrile (90:10, v\/v), and Solvent B consisting of 100% acetonitrile. The optimized parameters included a flow rate of 1.0\u2009mL\u2009min\n                    <jats:sup>\u22121<\/jats:sup>\n                    , a column temperature of 30\u2009\u00b0C, an injection volume of 25\u2009\u03bcL, and UV detection at 330\u2009nm. Method validation, conducted as per ICH Q2(R2) guidelines, confirmed excellent accuracy with recovery results between 97.0% and 103.0%. The method demonstrated linearity over a broad concentration range, from the limit of quantification (LOQ) to 200% of the target concentration, with correlation coefficients (\n                    <jats:italic>R<\/jats:italic>\n                    <jats:sup>2<\/jats:sup>\n                    ) exceeding 0.998 for all impurities. Precision, expressed as relative standard deviation (RSD), was consistently below 5.0%. Forced degradation studies indicated that rifapentine undergoes degradation under acidic, basic, oxidative, thermal, and photolytic conditions, thus confirming the stability\u2010indicating nature of the developed LC method.\n                  <\/jats:p>","DOI":"10.1002\/bmc.70430","type":"journal-article","created":{"date-parts":[[2026,3,23]],"date-time":"2026-03-23T05:25:39Z","timestamp":1774243539000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Quality by Design\u2010Based Development of a Robust LC Method for Simultaneous Estimation of Process\u2010 and Degradation\u2010Related Impurities in Rifapentine Drug Product for the Treatment of Active and Latent Tuberculosis"],"prefix":"10.1002","volume":"40","author":[{"given":"Siva\u00a0Prasad","family":"Korikana","sequence":"first","affiliation":[{"name":"Department of Chemistry GITAM School of Science, GITAM (Deemed to be University)  Visakhapatnam Andhra Pradesh India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0242-5032","authenticated-orcid":false,"given":"Sreenivasa\u00a0Rao","family":"Battula","sequence":"additional","affiliation":[{"name":"Department of Chemistry GITAM School of Science, GITAM (Deemed to be University)  Visakhapatnam Andhra Pradesh India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0815-9238","authenticated-orcid":false,"given":"Naresh","family":"Konduru","sequence":"additional","affiliation":[{"name":"Department of Chemistry GITAM School of Science, GITAM (Deemed to be University)  Visakhapatnam Andhra Pradesh India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4828-073X","authenticated-orcid":false,"given":"Aravind","family":"Kurnool","sequence":"additional","affiliation":[{"name":"Department of Chemistry, Sridevi Women's Engineering College Science and Humanities  Hyderabad Telangana India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Divya\u00a0Kumar","family":"Vemuri","sequence":"additional","affiliation":[{"name":"Department of Chemistry, GITAM School of Science GITAM Deemed to be University  Hyderabad Telangana India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-3371-2791","authenticated-orcid":false,"given":"Venkata\u00a0Lakshamana\u00a0Sagar","family":"Dantinapalli","sequence":"additional","affiliation":[{"name":"Department of Chemistry Raffles University  Alwar Rajasthan India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,3,22]]},"reference":[{"issue":"4","key":"e_1_2_10_2_1","first-page":"401","article-title":"Development and Validation of UV\/Visible Spectrophotometric Method for the Estimation of Rifapentine in Bulk and Pharmaceutical Formulations","volume":"1","author":"Ansari T.","year":"2013","journal-title":"American Journal of Phytomedicine and Clinical Therapeutics"},{"issue":"1","key":"e_1_2_10_3_1","first-page":"076","article-title":"Development and Validation of an RP\u2010HPLC Method for the Estimation of Rifapentine in Bulk and Pharmaceutical Formulation","volume":"2","author":"Ansari T.","year":"2014","journal-title":"American Journal of Advanced Drug Delivery"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/bmc.6062"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpha.2013.09.003"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.xphs.2023.12.011"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/bmc.70129"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/sscp.202300130"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpba.2016.02.013"},{"key":"e_1_2_10_10_1","unstructured":"ICH.1996. \u201cHarmonised Guideline \u2013 Stability Testing: Photostability Testing of New Drug Substances and Products Q1B.\u201dhttps:\/\/database.ich.org\/sites\/default\/files\/Q1B%20Guideline.pdf."},{"key":"e_1_2_10_11_1","unstructured":"ICH.2006. \u201cHarmonised Guideline \u2013 Impurities in New Drug Substances Q3A(R2).\u201dhttps:\/\/database.ich.org\/sites\/default\/files\/Q3A%28R2%29%20Guideline.pdf."},{"key":"e_1_2_10_12_1","unstructured":"ICH.2023. \u201cHarmonised Guideline \u2013 Validation of Analytical Procedures Q2 (R2).\u201dhttps:\/\/database.ich.org\/sites\/default\/files\/ICH_Q2%28R2%29_Guideline_2023_1130.pdf."},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/bmc.5062"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1080\/22297928.2019.1673814"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejpb.2025.114787"},{"issue":"2","key":"e_1_2_10_16_1","first-page":"99","article-title":"Analytical Method Development and Validation of Impurity Profile 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