{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,4]],"date-time":"2026-08-04T12:09:39Z","timestamp":1785845379676,"version":"3.56.0"},"reference-count":43,"publisher":"Elsevier BV","issue":"6","license":[{"start":{"date-parts":[[2025,11,1]],"date-time":"2025-11-01T00:00:00Z","timestamp":1761955200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2025,11,1]],"date-time":"2025-11-01T00:00:00Z","timestamp":1761955200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"}],"content-domain":{"domain":["clinicalkey.fr","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Annales Pharmaceutiques Fran\u00e7aises"],"published-print":{"date-parts":[[2025,11]]},"DOI":"10.1016\/j.pharma.2025.04.006","type":"journal-article","created":{"date-parts":[[2025,4,26]],"date-time":"2025-04-26T14:28:56Z","timestamp":1745677736000},"page":"1092-1113","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":11,"title":["Unspecified degradation impurities identification and characterization in bilastine and montelukast tablet formulations by using UPLC and LCMS\/MS: Robustness by design expert and green assessment"],"prefix":"10.1016","volume":"83","author":[{"given":"Raj Kumar","family":"Kodishala","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kousrali","family":"Sayyad","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leela Prasad","family":"Kowtharapu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naresh","family":"Konduru","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tanmoy","family":"Mondal","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohan","family":"Varkolu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sreedhar","family":"Gundekari","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.pharma.2025.04.006_bib0220","doi-asserted-by":"crossref","first-page":"371","DOI":"10.2165\/00126839-200506060-00005","article-title":"Preclinical pharmacology of bilastine, a new selective histamine H1 receptor antagonist","volume":"6","author":"Corcostegui","year":"2005","journal-title":"Drugs R&D"},{"key":"10.1016\/j.pharma.2025.04.006_bib0225","doi-asserted-by":"crossref","first-page":"33","DOI":"10.1586\/eci.11.87","article-title":"An overview of the novel H1-antihistamine bilastine in allergic rhinitis and urticaria","volume":"8","author":"J\u00e1uregui","year":"2011","journal-title":"Expert Rev Clin Immunol"},{"key":"10.1016\/j.pharma.2025.04.006_bib0230","doi-asserted-by":"crossref","first-page":"158","DOI":"10.1111\/j.1398-9995.2008.01813.x","article-title":"Comparison of the efficacy and safety of bilastine 20mg vs. desloratadine 5mg in seasonal allergic rhinitis patients","volume":"64","author":"Bachert","year":"2008","journal-title":"Allergy"},{"key":"10.1016\/j.pharma.2025.04.006_bib0235","doi-asserted-by":"crossref","first-page":"360","DOI":"10.1111\/j.1749-4486.2006.01276.x","article-title":"Montelukast in allergic rhinitis: a systematic review and meta-analysis","volume":"31","author":"Grainger","year":"2006","journal-title":"Clin Otolaryngol"},{"key":"10.1016\/j.pharma.2025.04.006_bib0240","doi-asserted-by":"crossref","first-page":"538","DOI":"10.1164\/rccm.201301-0023PP","article-title":"Anti-leukotriene agents for the treatment of lung disease","volume":"188","author":"Scott","year":"2013","journal-title":"Am J Respir Crit Care Med"},{"key":"10.1016\/j.pharma.2025.04.006_bib0245","doi-asserted-by":"crossref","first-page":"889","DOI":"10.1086\/511882","article-title":"Hepatotoxicity due to a drug interaction between amodiaquine plus artesunate and efavirenz","volume":"44","author":"German","year":"2007","journal-title":"Clin Infect Dis"},{"key":"10.1016\/j.pharma.2025.04.006_bib0250","doi-asserted-by":"crossref","first-page":"168","DOI":"10.1124\/pr.115.011411","article-title":"Role of cytochrome P450 2C8 in drug metabolism and interactions","volume":"68","author":"Backman","year":"2015","journal-title":"Pharmacol Rev"},{"key":"10.1016\/j.pharma.2025.04.006_bib0255","doi-asserted-by":"crossref","first-page":"242","DOI":"10.21276\/apjhs.2022.9.3.49","article-title":"Development and validation RP-HPLC method for simultaneous estimation of bilastine and montelukast in bulk and pharmaceutical dosage form","volume":"9","author":"Nizamuddin","year":"2022","journal-title":"Asian Pac J Health Sci"},{"key":"10.1016\/j.pharma.2025.04.006_bib0260","doi-asserted-by":"crossref","first-page":"8","DOI":"10.9734\/jpri\/2022\/v34i3B35388","article-title":"Simultaneous estimation of bilastine and montelukast in bulk by RP-HPLC and assessment of its applicability in marketed tablet dosage form","volume":"34","author":"Andhale","year":"2022","journal-title":"J Pharm Res Int"},{"key":"10.1016\/j.pharma.2025.04.006_bib0265","first-page":"199","article-title":"Development of RP-HPLC method for simultaneous determination of bilastine and montelukast by Qbd approach and its validation","volume":"13","author":"Aejaz","year":"2023","journal-title":"Int J Life Sci Pharma Res"},{"key":"10.1016\/j.pharma.2025.04.006_bib0270","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1186\/s13065-023-00953-y","article-title":"Green quality by design HPLC approach for the simultaneous determination of bilastine and montelukast","volume":"17","author":"Roshdy","year":"2023","journal-title":"BMC Chem"},{"key":"10.1016\/j.pharma.2025.04.006_bib0275","doi-asserted-by":"crossref","first-page":"68","DOI":"10.24092\/CRPS.2022.120110","article-title":"Development and validation of RP-HPLC based analytical method for simultaneous estimation of montelukast and bilastine in tablet dosage form","volume":"12","author":"Vyas","year":"2022","journal-title":"Curr Res Pharm Sci"},{"key":"10.1016\/j.pharma.2025.04.006_bib0280","first-page":"90","article-title":"Stability indicating RP-HPLC method development and validation for simultaneous estimation of montelukast and bilastine in bulk and pharmaceutical dosage form","volume":"10","author":"Sunkara","year":"2022","journal-title":"World J Pharm Res"},{"key":"10.1016\/j.pharma.2025.04.006_bib0285","first-page":"281","article-title":"Development and validation of reverse phase high performance liquid chromatography method for in-vitro dissolution testing of bilastine and montelukast sodium tablets","volume":"13","author":"Chandra","year":"2020","journal-title":"Int J Pharm Sci Drug Res"},{"key":"10.1016\/j.pharma.2025.04.006_bib0290","doi-asserted-by":"crossref","first-page":"210","DOI":"10.22159\/ijap.2021v13i6.41915","article-title":"Quantification of bilastine and montelukast combination in formulations utilizing liquid chromatography: stability studies","volume":"13","author":"Vijayalakshmi","year":"2021","journal-title":"Int J App Pharm"},{"key":"10.1016\/j.pharma.2025.04.006_bib0295","first-page":"132","article-title":"Stability indicating RP-HPLC method development and validation for simultaneous estimation of bilastine and montelukast in bulk and tablet dosage form","volume":"8","author":"Patil","year":"2023","journal-title":"Int J Pharm Sci Med"},{"key":"10.1016\/j.pharma.2025.04.006_bib0300","doi-asserted-by":"crossref","first-page":"1079","DOI":"10.52711\/0974-360X.2023.00180","article-title":"RP-HPLC method for quantification of bilastine and monteleukast sodium in pharmaceutical dosage form","volume":"16","author":"Bhanu","year":"2023","journal-title":"Res J Pharm Technol"},{"key":"10.1016\/j.pharma.2025.04.006_bib0305","doi-asserted-by":"crossref","first-page":"6061","DOI":"10.52711\/0974-360X.2021.01053","article-title":"Simultaneous HPLC method development and validation of bilastine and montelukast in bulk and formulation","volume":"14","author":"Shinde","year":"2021","journal-title":"Res J Pharm Technol"},{"key":"10.1016\/j.pharma.2025.04.006_bib0310","doi-asserted-by":"crossref","first-page":"708","DOI":"10.1016\/j.jpba.2008.07.007","article-title":"Identification, synthesis, isolation and spectral characterization of potential impurities of montelukast sodium","volume":"48","author":"Saravanan","year":"2008","journal-title":"J Pharm Biomed Anal"},{"key":"10.1016\/j.pharma.2025.04.006_bib0315","doi-asserted-by":"crossref","first-page":"90","DOI":"10.1016\/j.toxlet.2015.07.003","article-title":"Determination of the impurities in drug products containing montelukast and in silico\/in vitro genotoxicological assessments of sulfoxide impurity","volume":"238","author":"Emerce","year":"2015","journal-title":"Toxicol Lett"},{"key":"10.1016\/j.pharma.2025.04.006_bib0320","doi-asserted-by":"crossref","first-page":"4137","DOI":"10.1007\/s11696-022-02157-5","article-title":"Identification and synthesis of potential impurities of bilastine drug substance","volume":"76","author":"Reddy","year":"2022","journal-title":"Chem Pap"},{"key":"10.1016\/j.pharma.2025.04.006_bib0325","doi-asserted-by":"crossref","first-page":"e5850","DOI":"10.1002\/bmc.5850","article-title":"Analytical determination of ethylenediamine impurity in tripelennamine hydrochloride by gas chromatography-mass spectrometry using phthalaldehyde as the derivatizing agent","volume":"38","author":"Kousrali","year":"2024","journal-title":"Biomed Chromatogr"},{"key":"10.1016\/j.pharma.2025.04.006_bib0330","doi-asserted-by":"crossref","first-page":"e5920","DOI":"10.1002\/bmc.5920","article-title":"Gas chromatography mass spectrometer determination of dimethylamine impurity in N,N-dimethylformamide solvent by derivatization of N,N-dimethylbenzamide with benzoyl chloride agent","volume":"38","author":"Kousrali","year":"2024","journal-title":"Biomed Chromatogr"},{"key":"10.1016\/j.pharma.2025.04.006_bib0335","doi-asserted-by":"crossref","first-page":"921","DOI":"10.1093\/jaoacint\/qsae061","article-title":"Headspace gas chromatography mass spectrometry method for determination of class-I residual solvents in several drug substances: method evaluation by quality by design statistical tool","volume":"107","author":"Sayyad","year":"2024","journal-title":"J AOAC Int"},{"key":"10.1016\/j.pharma.2025.04.006_bib0340","doi-asserted-by":"crossref","first-page":"e202400118","DOI":"10.1002\/sscp.202400118","article-title":"Liquid chromatography-mass spectrometry method for determination of N-methyl-N-nitrosopyridin-4-amine in a vonoprazan fumarate drug","volume":"7","author":"Chilukuri","year":"2024","journal-title":"Sep Sci Plus"},{"key":"10.1016\/j.pharma.2025.04.006_bib0345","doi-asserted-by":"crossref","first-page":"1173","DOI":"10.5530\/ijper.55.4.217","article-title":"Development and validation of analytical method for quantitative estimation of multiple metal impurities in dobutamine hydrochloride using ICPMS spectroscopy","volume":"55","author":"Ali","year":"2021","journal-title":"Indian J Pharm Educ Res"},{"key":"10.1016\/j.pharma.2025.04.006_bib0350","doi-asserted-by":"crossref","first-page":"e6086","DOI":"10.1002\/bmc.6086","article-title":"Bioanalytical tandem mass spectrometry method for precise measurement of tranexamic acid in human plasma with unveiling methodological advancement: green assessment with advanced metrics","volume":"39","author":"Kollapareddy","year":"2025","journal-title":"Biomed Chromatogr"},{"key":"10.1016\/j.pharma.2025.04.006_bib0355","series-title":"Validation of analytical procedures: text and methodology Q2 (R2)","year":"2023"},{"key":"10.1016\/j.pharma.2025.04.006_bib0360","doi-asserted-by":"crossref","first-page":"e5359","DOI":"10.1002\/bmc.5359","article-title":"A quality by design and green LC technique for the determination of mast cell stabilizer and histamine receptor antagonist (olopatadine HCl) in multiple formulations","volume":"36","author":"Kowtharapu","year":"2022","journal-title":"Biomed Chromatogr"},{"key":"10.1016\/j.pharma.2025.04.006_bib0365","doi-asserted-by":"crossref","first-page":"530","DOI":"10.1002\/sscp.202000029","article-title":"A simple high-performance liquid chromatography method development for carbidopa and levodopa impurities: evaluation of risk assessment before method validation by quality by design approach","volume":"3","author":"Subramanian","year":"2020","journal-title":"Sep Sci Plus"},{"key":"10.1016\/j.pharma.2025.04.006_bib0370","doi-asserted-by":"crossref","first-page":"254","DOI":"10.1002\/sscp.202100063","article-title":"Development and validation of liquid chromatography method for determination of ibrutinib in finished dosage forms using quality by design approach","volume":"5","author":"Konduru","year":"2022","journal-title":"Sep Sci Plus"},{"key":"10.1016\/j.pharma.2025.04.006_bib0375","doi-asserted-by":"crossref","first-page":"e5486","DOI":"10.1002\/bmc.5486","article-title":"Development and validation of novel RP-HPLC method for midostaurin determination using analytical quality by design approach from regulatory perspective and determination of major degradation compounds of midostaurin using LC-MS","volume":"36","author":"Saddala","year":"2022","journal-title":"Biomed Chromatogr"},{"key":"10.1016\/j.pharma.2025.04.006_bib0380","doi-asserted-by":"crossref","first-page":"e5580","DOI":"10.1002\/bmc.5580","article-title":"QbD-based stability-indicating liquid chromatography (RP-HPLC) method for the determination of flurbiprofen in cataplasm","volume":"37","author":"Nathi","year":"2023","journal-title":"Biomed Chromatogr"},{"key":"10.1016\/j.pharma.2025.04.006_bib0385","doi-asserted-by":"crossref","first-page":"e5449","DOI":"10.1002\/bmc.5449","article-title":"Unique liquid chromatography technique for the determination of mirabegron in the presence of polymers; robustness by design expert in the light of quality by design","volume":"36","author":"Konduru","year":"2022","journal-title":"Biomed Chromatogr"},{"key":"10.1016\/j.pharma.2025.04.006_bib0390","doi-asserted-by":"crossref","first-page":"117196","DOI":"10.1016\/j.trac.2023.117196","article-title":"Green metric tools for analytical methods assessment critical review, case studies and crucify","volume":"166","author":"Kowtharapu","year":"2023","journal-title":"TrAC Trends Analyt Chem"},{"key":"10.1016\/j.pharma.2025.04.006_bib0395","doi-asserted-by":"crossref","first-page":"1711","DOI":"10.1002\/jssc.202100979","article-title":"Unique green chromatography method for the determination of serotonin receptor antagonist (Ondansetron hydrochloride) related substances in a liquid formulation, robustness by quality by design-based design of experiments approach","volume":"45","author":"Kowtharapu","year":"2022","journal-title":"J Sep Sci"},{"key":"10.1016\/j.pharma.2025.04.006_bib0400","doi-asserted-by":"crossref","first-page":"19138","DOI":"10.1038\/s41598-022-22998-0","article-title":"AQbD based green UPLC method to determine mycophenolate mofetil impurities and Identification of degradation products by QToF LCMS","volume":"12","author":"Muchakayala","year":"2022","journal-title":"Sci Rep"},{"key":"10.1016\/j.pharma.2025.04.006_bib0405","doi-asserted-by":"crossref","first-page":"34098","DOI":"10.1021\/acsomega.2c03387","article-title":"Green chromatographic method for determination of active pharmaceutical ingredient, preservative, and antioxidant in an injectable formulation: robustness by design expert","volume":"7","author":"Kowtharapu","year":"2022","journal-title":"ACS Omega"},{"key":"10.1016\/j.pharma.2025.04.006_bib0410","doi-asserted-by":"crossref","first-page":"1407","DOI":"10.1021\/acs.joc.3c01871","article-title":"Sustainable synthesis of indole-substituted densely functionalized pyrrole","volume":"89","author":"Vinod","year":"2024","journal-title":"J Org Chem"},{"key":"10.1016\/j.pharma.2025.04.006_bib0415","doi-asserted-by":"crossref","first-page":"101079","DOI":"10.1016\/j.scp.2023.101079","article-title":"QbD green analytical procedure for novel study of a genotoxic and carcinogenic compound trace determination in physiological solution compatibility","volume":"33","author":"Kowtharapu","year":"2023","journal-title":"Sustain Chem Pharm"},{"key":"10.1016\/j.pharma.2025.04.006_bib0420","doi-asserted-by":"crossref","first-page":"101247","DOI":"10.1016\/j.scp.2023.101247","article-title":"Unique green chromatographic method for the qualitative and quantitative analysis of ketoconazole, its impurities and preservatives from ketoconazole cream formulation: identification of degradants by Q-ToF LCMS and robustness by design of experiments","volume":"36","author":"Muchakayala","year":"2023","journal-title":"Sustain Chem Pharm"},{"key":"10.1016\/j.pharma.2025.04.006_bib0425","doi-asserted-by":"crossref","first-page":"113","DOI":"10.1080\/22297928.2019.1673814","article-title":"Development and validation of a stability-indicating method for ibrutinib: identification and separation of degradation products, known and genotoxic impurities using RP-HPLC\/PDA and QDa mass detectors","volume":"10","author":"Konduru","year":"2020","journal-title":"Anal Chem Lett"},{"key":"10.1016\/j.pharma.2025.04.006_bib0430","doi-asserted-by":"crossref","first-page":"e5246","DOI":"10.1002\/bmc.5246","article-title":"Determination of progesterone (steroid drug) in the semi-solid dosage form (vaginal gel) using a stability-indicating method by RP-HPLC\/PDA detector","volume":"36","author":"Konduru","year":"2021","journal-title":"Biomed Chromatogr"}],"container-title":["Annales Pharmaceutiques Fran\u00e7aises"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0003450925000768?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0003450925000768?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2025,11,2]],"date-time":"2025-11-02T12:26:43Z","timestamp":1762086403000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0003450925000768"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,11]]},"references-count":43,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2025,11]]}},"alternative-id":["S0003450925000768"],"URL":"https:\/\/doi.org\/10.1016\/j.pharma.2025.04.006","relation":{},"ISSN":["0003-4509"],"issn-type":[{"value":"0003-4509","type":"print"}],"subject":[],"published":{"date-parts":[[2025,11]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Unspecified degradation impurities identification and characterization in bilastine and montelukast tablet formulations by using UPLC and LCMS\/MS: Robustness by design expert and green assessment","name":"articletitle","label":"Article Title"},{"value":"Annales Pharmaceutiques Fran\u00e7aises","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.pharma.2025.04.006","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2025 Acad\u00e9mie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights are reserved, including those for text and data mining, AI training, and similar technologies.","name":"copyright","label":"Copyright"}]}}