{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,23]],"date-time":"2026-08-23T17:59:06Z","timestamp":1787507946702,"version":"build-2736575974"},"reference-count":34,"publisher":"Elsevier BV","issue":"8","license":[{"start":{"date-parts":[[2025,8,1]],"date-time":"2025-08-01T00:00:00Z","timestamp":1754006400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2025,8,1]],"date-time":"2025-08-01T00:00:00Z","timestamp":1754006400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"}],"funder":[{"DOI":"10.13039\/501100004586","name":"Carlos Chagas Filho Foundation for Research Support of Rio de Janeiro State","doi-asserted-by":"publisher","award":["E-26\/210.474\/2024"],"award-info":[{"award-number":["E-26\/210.474\/2024"]}],"id":[{"id":"10.13039\/501100004586","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["jpharmsci.org","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Journal of Pharmaceutical Sciences"],"published-print":{"date-parts":[[2025,8]]},"DOI":"10.1016\/j.xphs.2025.103863","type":"journal-article","created":{"date-parts":[[2025,6,5]],"date-time":"2025-06-05T20:11:48Z","timestamp":1749154308000},"page":"103863","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":2,"title":["Development and validation of quality by design stability-indicating method for quantitative determination of lamivudine and its impurities"],"prefix":"10.1016","volume":"114","author":[{"given":"Thamara","family":"de Carvalho Mendes","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rayza Adrielle Dias","family":"de Almeida","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fl\u00e1via Furtado","family":"de Mendon\u00e7a Sousa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diogo Dibo","family":"do Nascimento","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Camila Areias","family":"de Oliveira","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5691-9900","authenticated-orcid":false,"given":"Livia Deris","family":"Prado","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.xphs.2025.103863_bib0001","doi-asserted-by":"crossref","first-page":"1784","DOI":"10.1021\/acs.oprd.9b00238","article-title":"Development and optimization of liquid chromatography analytical methods by using AQbD principles: overview and recent advances","volume":"23","author":"Tome","year":"2019","journal-title":"Org Process Res Dev"},{"key":"10.1016\/j.xphs.2025.103863_bib0002","doi-asserted-by":"crossref","first-page":"19","DOI":"10.1016\/j.ejpb.2019.12.007","article-title":"Quality by design in pharmaceutical manufacturing: a systematic review of current status, challenges and future perspectives","volume":"147","author":"Grangeia","year":"2020","journal-title":"Eur J Pharm Biopharm"},{"key":"10.1016\/j.xphs.2025.103863_bib0003","unstructured":"International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). 2009. ICH Q8 - step 5: pharmaceutical development. Available at: https:\/\/www.ich.org\/page\/quality-guidelines. Accessed on: September 19, 2024."},{"key":"10.1016\/j.xphs.2025.103863_bib0004","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1080\/03639045.2022.2102647","article-title":"Efficient drug development of oseltamivir capsules based on process control, bioequivalence and PBPK modeling","volume":"48","author":"Medeiros","year":"2022","journal-title":"Drug Dev Ind Pharm"},{"key":"10.1016\/j.xphs.2025.103863_bib0005","doi-asserted-by":"crossref","first-page":"771","DOI":"10.1208\/s12248-014-9598-3","article-title":"Understanding pharmaceutical quality by design","volume":"16","author":"Yu","year":"2014","journal-title":"AAPS J"},{"key":"10.1016\/j.xphs.2025.103863_bib0006","doi-asserted-by":"crossref","first-page":"559","DOI":"10.1021\/acs.analchem.1c03854","article-title":"Selection of analytical technology and development of analytical procedures using the analytical target profile","volume":"94","author":"Borman","year":"2021","journal-title":"Anal Chem"},{"key":"10.1016\/j.xphs.2025.103863_bib0007","article-title":"Prednisone raw material characterization and formulation development","volume":"53","author":"Toehw\u00e9","year":"2017","journal-title":"Braz J Pharm Sci"},{"key":"10.1016\/j.xphs.2025.103863_bib0008","doi-asserted-by":"crossref","first-page":"136","DOI":"10.14227\/DT310324P136","article-title":"Life cycle application of AQbD for formulation development and validation of a dissolution method for Nevirapine","volume":"31","author":"de Almeida","year":"2024","journal-title":"Dissol Technol"},{"key":"10.1016\/j.xphs.2025.103863_bib0009","doi-asserted-by":"crossref","first-page":"3011","DOI":"10.1208\/s12249-017-0781-6","article-title":"Efavirenz dissolution enhancement IV\u2014Antisolvent nanocrystallization by sonication, physical stability, and dissolution","volume":"18","author":"Sartori","year":"2017","journal-title":"AAPS PharmSciTech"},{"key":"10.1016\/j.xphs.2025.103863_bib0010","article-title":"Pharmaceutical development of micro and nanocrystals of a poorly water-soluble drug: dissolution rate enhancement of praziquantel","volume":"81","author":"Silva","year":"2023","journal-title":"J Drug Deliv Sci Tech"},{"key":"10.1016\/j.xphs.2025.103863_bib0011","article-title":"Application of analytical quality by design (AQbD) for stability-indicating method development for quantification of nevirapine and its degradation products","volume":"199","author":"Lopes","year":"2024","journal-title":"Microchem J"},{"key":"10.1016\/j.xphs.2025.103863_bib0012","doi-asserted-by":"crossref","first-page":"797","DOI":"10.1002\/jps.22325","article-title":"Development of quality-by-design analytical methods","volume":"100","author":"Vogt","year":"2011","journal-title":"J Pharm Sci"},{"key":"10.1016\/j.xphs.2025.103863_bib0013","series-title":"General Chapter, \u30081220\u3009 Analytical Procedure Life Cycle. USP-NF","year":"2024"},{"key":"10.1016\/j.xphs.2025.103863_bib0014","unstructured":"International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). 2024. ICH Q14 - step 5: analytical procedure development. Available at: https:\/\/www.ich.org\/page\/quality-guidelines. Accessed on: September 19, 2024."},{"key":"10.1016\/j.xphs.2025.103863_bib0015","doi-asserted-by":"crossref","first-page":"34","DOI":"10.1208\/s12248-022-00685-2","article-title":"Analytical quality by design, life cycle management, and method control","volume":"24","author":"Verch","year":"2022","journal-title":"AAPS J"},{"key":"10.1016\/j.xphs.2025.103863_bib0016","doi-asserted-by":"crossref","first-page":"2577","DOI":"10.1021\/acs.analchem.8b04596","article-title":"Using the analytical target profile to drive the analytical method lifecycle","volume":"91","author":"Jackson","year":"2019","journal-title":"Anal Chem"},{"key":"10.1016\/j.xphs.2025.103863_bib0017","doi-asserted-by":"crossref","first-page":"110","DOI":"10.1016\/j.jpba.2018.07.050","article-title":"Risk-based approach for method development in pharmaceutical quality control context: a critical review","volume":"161","author":"Deidda","year":"2018","journal-title":"J Pharm Biomed Anal"},{"key":"10.1016\/j.xphs.2025.103863_bib0018","doi-asserted-by":"crossref","first-page":"88","DOI":"10.1016\/j.chroma.2015.03.059","article-title":"Towards a full integration of optimization and validation phases: an analytical-quality-by-design approach","volume":"1395","author":"Hubert","year":"2015","journal-title":"J Chromatogr A"},{"key":"10.1016\/j.xphs.2025.103863_bib0019","doi-asserted-by":"crossref","first-page":"326","DOI":"10.1016\/j.jpba.2019.01.032","article-title":"Analytical quality by design: development and control strategy for a LC method to evaluate the cannabinoids content in cannabis olive oil extracts","volume":"166","author":"Deidda","year":"2019","journal-title":"J Pharm Biomed Anal"},{"key":"10.1016\/j.xphs.2025.103863_bib0020","article-title":"Definitions and scope of analytical quality by design (AQbD) key elements for method development in the pharmaceutical industry","volume":"11","author":"Moure","year":"2023","journal-title":"Vigil Sanit Debate"},{"key":"10.1016\/j.xphs.2025.103863_bib0021","doi-asserted-by":"crossref","DOI":"10.1016\/j.talanta.2023.124481","article-title":"Development and optimization of a LC-MS\/MS compatible method for quantification of losartan, hydrochlorothiazide and their impurities using AQbD approach and measurement uncertainty evaluation","volume":"259","author":"Rocha","year":"2023","journal-title":"Talanta"},{"key":"10.1016\/j.xphs.2025.103863_bib0022","doi-asserted-by":"crossref","first-page":"3340","DOI":"10.1016\/j.xphs.2022.08.025","article-title":"Novel eco-friendly stability indicating capillary zone electrophoresis method for determination of aripiprazole in tablet dosage form: DoE directed optimization, development and method validation","volume":"111","author":"Fajardo","year":"2022","journal-title":"J Pharm Sci"},{"key":"10.1016\/j.xphs.2025.103863_bib0023","doi-asserted-by":"crossref","first-page":"2542","DOI":"10.1016\/j.xphs.2024.05.028","article-title":"Identification and characterization of rotigotine degradation products by HPLC coupled DAD and CAD detectors and HRMS through Q-orbitrap and electrospray ionization","volume":"113","author":"Mendes","year":"2024","journal-title":"J Pharm Sci"},{"key":"10.1016\/j.xphs.2025.103863_bib0024","doi-asserted-by":"crossref","DOI":"10.1016\/j.chroma.2022.463380","article-title":"Implementation of analytical quality by design and green chemistry principles to develop an ultra-high performance liquid chromatography method for the determination of fluocinolone acetonide impurities from its drug substance and topical oil formulations","volume":"1679","author":"Muchakayala","year":"2022","journal-title":"J Chromatogr A"},{"key":"10.1016\/j.xphs.2025.103863_bib0025","doi-asserted-by":"crossref","DOI":"10.1016\/j.microc.2021.106968","article-title":"Environmental benign AQbD based estimation of ketoconazole and beclomethasone by RP-HPLC and multi-analytical UV spectrophotometric method","volume":"172","author":"Kannaiah","year":"2022","journal-title":"Microchem J"},{"issue":"12","key":"10.1016\/j.xphs.2025.103863_bib0026","doi-asserted-by":"crossref","first-page":"2948","DOI":"10.1016\/j.xphs.2023.09.003","article-title":"Pharmaceutical forced degradation (Stress Testing) endpoints: a scientific rationale and industry perspective","volume":"112","author":"Zelesky","year":"2023","journal-title":"J Pharm Sci"},{"key":"10.1016\/j.xphs.2025.103863_bib0027","doi-asserted-by":"crossref","first-page":"213","DOI":"10.1365\/s10337-004-0367-9","article-title":"The international conference on harmonisation guidance in practice: stress degradation studies on lamivudine and development of a validated specific stability-indicating HPTLC assay method","volume":"60","author":"Kaul","year":"2004","journal-title":"Chromatographia"},{"key":"10.1016\/j.xphs.2025.103863_bib0028","doi-asserted-by":"crossref","unstructured":"United States Pharmacopeia (USP). USP Monographs, Lamivudine. USP-NF. Rockville, MD: United States Pharmacopeia. https:\/\/doi.org\/10.31003\/USPNF_M44243_02_01.","DOI":"10.31003\/USPNF_M44243_02_01"},{"key":"10.1016\/j.xphs.2025.103863_bib0029","doi-asserted-by":"crossref","unstructured":"United States Pharmacopeia (USP). USP Monographs, Lamivudine Tablets. USP-NF. Rockville, MD: United States Pharmacopeia. https:\/\/doi.org\/10.31003\/USPNF_M2881_02_01.","DOI":"10.31003\/USPNF_M2881_02_01"},{"key":"10.1016\/j.xphs.2025.103863_bib0030","doi-asserted-by":"crossref","first-page":"2273","DOI":"10.1590\/S0102-311X2009001000017","article-title":"Antiretroviral manufacturers and the challenge of universal access to drugs through the Brazilian National STD\/AIDS Program","volume":"25","author":"Lago","year":"2009","journal-title":"Cad Sa\u00fade P\u00fablica"},{"key":"10.1016\/j.xphs.2025.103863_bib0031","unstructured":"Official Medicines Control Laboratories (OMCL). 2019. Evaluation of measurement uncertainty annex 2.1: use of data from validation studies for the estimation of measurement uncertainty."},{"key":"10.1016\/j.xphs.2025.103863_bib0032","unstructured":"Eurachem\/CITAC Guide. 2015. Setting and using target uncertainty in chemical measurement."},{"key":"10.1016\/j.xphs.2025.103863_bib0033","unstructured":"Association of Official Agricultural Chemists - AOAC International. 2012. Official methods of analysis of AOAC International, in Guidelines for Standard Method Performance Requirements (Appendix F)."},{"key":"10.1016\/j.xphs.2025.103863_bib0034","unstructured":"Eurachem\/CITAC Guide. 2021. Use of uncertainty information in compliance assessment."}],"container-title":["Journal of Pharmaceutical Sciences"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0022354925003156?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0022354925003156?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2025,8,28]],"date-time":"2025-08-28T18:13:28Z","timestamp":1756404808000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0022354925003156"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,8]]},"references-count":34,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2025,8]]}},"alternative-id":["S0022354925003156"],"URL":"https:\/\/doi.org\/10.1016\/j.xphs.2025.103863","relation":{},"ISSN":["0022-3549"],"issn-type":[{"value":"0022-3549","type":"print"}],"subject":[],"published":{"date-parts":[[2025,8]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Development and validation of quality by design stability-indicating method for quantitative determination of lamivudine and its impurities","name":"articletitle","label":"Article Title"},{"value":"Journal of Pharmaceutical Sciences","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.xphs.2025.103863","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2025 American Pharmacists Association. Published by Elsevier Inc. All rights are reserved, including those for text and data mining, AI training, and similar technologies.","name":"copyright","label":"Copyright"}],"article-number":"103863"}}