{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,29]],"date-time":"2025-12-29T12:23:30Z","timestamp":1767011010957,"version":"3.48.0"},"reference-count":37,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2025,12,27]],"date-time":"2025-12-27T00:00:00Z","timestamp":1766793600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,12,27]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Terbutaline sulfate is a pediatric \u03b22-adrenergic agonist that acts as a bronchodilator by stimulating \u03b22-adrenoceptors in bronchial smooth muscle. A novel and reliable high-performance liquid chromatography method was developed to identify process- and degradation-related impurities in terbutaline sulfate oral syrup. The separation was achieved using an Inertsil ODS-3 column (250\u2009\u00d7\u20094.6\u00a0mm, 5\u00a0\u03bcm) maintained at 30\u00b0C, with a mobile phase composed of buffer and acetonitrile delivered at a flow rate of 1.0\u00a0mL\/min under a linear gradient elution mode. The injection volume and sample concentration were set at 40 \u03bcL and 500\u00a0\u03bcg\/mL, respectively. The drug and its impurities demonstrated good linearity, with determination coefficients greater than 0.999. Recovery rates at all levels ranged from 95% to 105%. Forced degradation studies were conducted under acidic, alkaline, oxidative, thermal and photolytic forced degradation conditions. Under photolytic forced degradation, Imp-B and three furfural-related degradation impurities were formed. The validated stability-indicating HPLC method, which has been verified in accordance with International Conference on Harmonisation guidelines, is suitable for both stability studies and routine quality control.<\/jats:p>","DOI":"10.1093\/chromsci\/bmaf064","type":"journal-article","created":{"date-parts":[[2025,12,12]],"date-time":"2025-12-12T13:11:19Z","timestamp":1765545079000},"source":"Crossref","is-referenced-by-count":0,"title":["Development and Validation of an HPLC Method for Impurity Profiling in Terbutaline Sulfate Oral Syrup"],"prefix":"10.1093","volume":"64","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4083-044X","authenticated-orcid":false,"given":"Renming","family":"Yang","sequence":"first","affiliation":[{"name":"Sichuan Aupone GOOD Pharmaceutical Co., Ltd. , Baicao Road No 990, Hi-Tech Industrial Development Zone, Chengdu 610097 ,","place":["China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Qin","family":"Zeng","sequence":"additional","affiliation":[{"name":"Sichuan Aupone GOOD Pharmaceutical Co., Ltd. , Baicao Road No 990, Hi-Tech Industrial Development Zone, Chengdu 610097 ,","place":["China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Likai","family":"Yang","sequence":"additional","affiliation":[{"name":"Sichuan Aupone GOOD Pharmaceutical Co., Ltd. , Baicao Road No 990, Hi-Tech Industrial Development Zone, Chengdu 610097 ,","place":["China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yayi","family":"Yang","sequence":"additional","affiliation":[{"name":"Sichuan Aupone GOOD Pharmaceutical Co., Ltd. , Baicao Road No 990, Hi-Tech Industrial Development Zone, Chengdu 610097 ,","place":["China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zhongjun","family":"Jiang","sequence":"additional","affiliation":[{"name":"Sichuan Aupone GOOD Pharmaceutical Co., Ltd. , Baicao Road No 990, Hi-Tech Industrial Development Zone, Chengdu 610097 ,","place":["China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chun","family":"Wang","sequence":"additional","affiliation":[{"name":"Sichuan Aupone GOOD Pharmaceutical Co., Ltd. , Baicao Road No 990, Hi-Tech Industrial Development Zone, Chengdu 610097 ,","place":["China"]}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2025,12,29]]},"reference":[{"key":"2025122907205130600_ref1","doi-asserted-by":"crossref","first-page":"114416","DOI":"10.1016\/j.jpba.2021.114416","article-title":"Identification of novel impurity of ziprasidone","volume":"207","author":"Murkute","year":"2022","journal-title":"Journal of Pharmaceutical and Biomedical Analysis"},{"issue":"7","key":"2025122907205130600_ref2","doi-asserted-by":"publisher","first-page":"2019","DOI":"10.1016\/j.xphs.2016.03.019","article-title":"An overview of pharmaceutical excipients: Safe or not safe?","volume":"105","author":"Abrantes","year":"2016","journal-title":"Journal of Pharmaceutical Sciences"},{"key":"2025122907205130600_ref3","doi-asserted-by":"crossref","first-page":"120962","DOI":"10.1016\/j.ijpharm.2021.120962","article-title":"PharmDE: A new expert system for drug-excipient compatibility evaluation","volume":"607","author":"Wang","year":"2021","journal-title":"International Journal of Pharmaceutics"},{"issue":"9","key":"2025122907205130600_ref4","doi-asserted-by":"crossref","first-page":"2283","DOI":"10.3390\/pharmaceutics15092283","article-title":"Development of a carvedilol oral liquid formulation for paediatric use","volume":"15","author":"Rodr\u00edguez","year":"2023","journal-title":"Pharmaceutics"},{"issue":"2","key":"2025122907205130600_ref5","doi-asserted-by":"publisher","first-page":"682","DOI":"10.1016\/j.xphs.2020.09.054","article-title":"Detection and characterization of an unknown impurity in levothyroxine oral solution product: Implications for formulation development and storage","volume":"110","author":"Sreeramoju","year":"2021","journal-title":"Journal of Pharmaceutical Sciences"},{"key":"2025122907205130600_ref6","doi-asserted-by":"publisher","first-page":"4","DOI":"10.1002\/sscp.201900084","article-title":"UHPLC assay and impurity methods for diphenhydramine and phenylephrine hydrochloride oral solution","volume":"3","author":"Kirkpatrick","year":"2020","journal-title":"Separation Science Plus"},{"key":"2025122907205130600_ref7","first-page":"334","article-title":"Structure elucidation and quantification of impurities formed between 6-aminocaproic acid and the excipients citric acid and sorbitol in an oral solution using high-resolution mass spectrometry and nuclear magnetic resonance spectroscopy","volume":"107","author":"Anne","year":"2015","journal-title":"Journal of Pharmaceutical and Biomedical Analysis"},{"issue":"3","key":"2025122907205130600_ref8","doi-asserted-by":"crossref","first-page":"517","DOI":"10.1590\/s1984-82502016000300017","article-title":"Analysis of extemporaneous oral liquid from commercially available drugs in hospital","volume":"52","author":"Benzi","year":"2016","journal-title":"Brazilian Journal of Pharmaceutical Sciences"},{"key":"2025122907205130600_ref9","doi-asserted-by":"crossref","first-page":"93","DOI":"10.4038\/cmj.v61i3.8340","article-title":"Time to change the paradigm of children\u2019s medicines from liquid formulations to flexible solid oral dosage forms","volume":"61","author":"Hoppu","year":"2016","journal-title":"Ceylon Medical Journal"},{"key":"2025122907205130600_ref10","doi-asserted-by":"crossref","first-page":"252","DOI":"10.1016\/j.cej.2019.02.183","article-title":"Sulfate radical induced degradation of \u03b22-adrenoceptor agonists salbutamol and terbutaline: Implication of halides, bicarbonate, and natural organic matter","volume":"36","author":"Zhou","year":"2019","journal-title":"Chemical Engineering Journal"},{"issue":"5","key":"2025122907205130600_ref11","doi-asserted-by":"publisher","first-page":"1204","DOI":"10.3109\/10837450.2011.620968","article-title":"Formulation and in vitro assessment of sustained release terbutaline sulfate tablet made from binary hydrophilic polymer mixtures","volume":"18","author":"Al-Akayleh","year":"2013","journal-title":"Pharmaceutical Development and Technology"},{"key":"2025122907205130600_ref12","doi-asserted-by":"crossref","first-page":"727","DOI":"10.1208\/s12249-015-0404-z","article-title":"Formulation and in vitro and in vivo evaluation of lipid-based terbutaline sulphate Bi-layer tablets for once-daily administration","volume":"17","author":"Hashem","year":"2016","journal-title":"AAPS PharmSciTech"},{"key":"2025122907205130600_ref13","doi-asserted-by":"publisher","first-page":"1707","DOI":"10.1007\/s11095-017-2178-3","article-title":"Effect of relative humidity on bipolar electrostatic charge profiles of dry powder aerosols","volume":"34","author":"Yu","year":"2017","journal-title":"Pharmaceutical Research"},{"key":"2025122907205130600_ref14","doi-asserted-by":"crossref","first-page":"19","DOI":"10.1089\/jamp.2008.0650","article-title":"Aerodynamic characteristics of nebulized terbutaline sulphate using the next generation impactor (NGI) and CEN method","volume":"22","author":"Abdelrahim","year":"2009","journal-title":"Journal of Aerosol Medicine and Pulmonary Drug Delivery"},{"key":"2025122907205130600_ref15","doi-asserted-by":"crossref","first-page":"1507","DOI":"10.1007\/s10337-016-3158-1","article-title":"A versatile HPLC method for the simultaneous determination of bromhexine, guaifenesin, Ambroxol, salbutamol\/terbutaline, pseudoephedrine, triprolidine, and chlorpheniramine maleate in cough\u2013cold syrups","volume":"79","author":"Njaria","year":"2016","journal-title":"Chromatographia"},{"key":"2025122907205130600_ref16","doi-asserted-by":"crossref","first-page":"381","DOI":"10.1007\/s10337-021-04021-2","article-title":"Identification and characterization of a new process related impurity in terbutaline sulfate by accurate-mass Q-TOF LC\/MS\/MS and NMR","volume":"84","author":"Patil","year":"2021","journal-title":"Chromatographia"},{"key":"2025122907205130600_ref17","doi-asserted-by":"crossref","first-page":"793","DOI":"10.1007\/s10337-017-3259-5","article-title":"Identification of degradation products and process impurities from terbutaline sulfate by UHPLC-Q-TOF-MS\/MS and in silico toxicity prediction","volume":"80","author":"Zhou","year":"2017","journal-title":"Chromatographia"},{"issue":"11","key":"2025122907205130600_ref18","doi-asserted-by":"crossref","first-page":"1181","DOI":"10.1002\/jctb.7621","article-title":"Chiral separation of terbutaline by supercritical fluid chromatography with peak purity determination by UPLC\u2013MS and modeling for chiral recognition mechanism","volume":"99","author":"Ali","year":"2024","journal-title":"Journal of Chemical Technology and Biotechnology"},{"issue":"6","key":"2025122907205130600_ref19","doi-asserted-by":"publisher","first-page":"759","DOI":"10.1002\/chir.22846","article-title":"Enantioselective resolution of rac-terbutaline and evaluation of optically pure R-terbutaline hydrochloride as an efficient anti-asthm chirality atic drug","volume":"30","author":"Beng","year":"2018","journal-title":"Chirality"},{"key":"2025122907205130600_ref20","doi-asserted-by":"crossref","first-page":"512","DOI":"10.1039\/D0JA00519C","article-title":"Development of a sample preparation method for accurate analysis of 24 elemental impurities in oral drug products by ICP-MS according to USP\/ICH guidelines","volume":"36","author":"Gu","year":"2012","journal-title":"Journal of Analytical Atomic Spectrometry"},{"key":"2025122907205130600_ref21"},{"key":"2025122907205130600_ref22"},{"key":"2025122907205130600_ref23","doi-asserted-by":"crossref","first-page":"115435","DOI":"10.1016\/j.jpba.2023.115435","article-title":"HPLC separation, synthesis, isolation and characterization of process related and degradation impurities in larotaxel including method development and validation","volume":"233","author":"Yao","year":"2023","journal-title":"Journal of Pharmaceutical and Biomedical Analysis"},{"issue":"10","key":"2025122907205130600_ref24","doi-asserted-by":"crossref","first-page":"978","DOI":"10.1093\/chromsci\/bmad065","article-title":"Using the AQbD approach, developmentand validation of a simple, rapid stability indicating chromatographic method for quantification of related impurities of apixaban","volume":"62","author":"Jayasri","year":"2024","journal-title":"Journal of Chromatographic Science"},{"issue":"8","key":"2025122907205130600_ref25","first-page":"919","article-title":"Uplc\u2013pda approach for simultaneous quantification of elvitegravir, tenofovir, emtricitabine and cobicistat in tablets: An ms-esi study for degradation products","volume":"62","author":"Rajya","year":"2024","journal-title":"Journal of Chromatographic Science"},{"key":"2025122907205130600_ref26"},{"issue":"4","key":"2025122907205130600_ref27","first-page":"1","article-title":"Stability indicating high performance liquid chromatography method development, validation, and characterization of forced degradant product by liquid chromatography-mass spectroscopy for molnupiravir and favipiravir","volume":"63","author":"Trupesh","year":"2025","journal-title":"Journal of Chromatographic Science"},{"issue":"4","key":"2025122907205130600_ref28","first-page":"1","article-title":"RP-HPLC method development and validation for simultaneous estimation of berberine and ursolic acid in formulation","volume":"63","author":"Vineeta","year":"2025","journal-title":"Journal of Chromatographic Science"},{"issue":"1","key":"2025122907205130600_ref29","first-page":"1","article-title":"Structural elucidation of novel degradation impurities of ibrutinib in ibrutinib tablets using preparative chromatography, LCMS, HRMS and 2D NMR techniques","volume":"63","author":"Rajender","year":"2025","journal-title":"Journal of Chromatographic Science"},{"key":"2025122907205130600_ref30","doi-asserted-by":"crossref","first-page":"115568","DOI":"10.1016\/j.jpba.2023.115568","article-title":"The first RP-UHPLC method for simultaneous quantification of abiraterone acetate, its four degradants, and six specified process impurities and correct identification of all analytes based on molecular weight","volume":"234","author":"Mhaske","year":"2023","journal-title":"Journal of Pharmaceutical and Biomedical Analysis"},{"key":"2025122907205130600_ref31"},{"key":"2025122907205130600_ref32"},{"key":"2025122907205130600_ref33","doi-asserted-by":"crossref","first-page":"593","DOI":"10.1016\/j.jscs.2012.01.006","article-title":"Development and validation of a stability-indicating LC method for simultaneous determination of related compounds of guaifenesin, terbutaline sulfate and ambroxol HCl in cough syrup formulation","volume":"18","author":"Rao","year":"2014","journal-title":"Journal of Saudi Chemical Society"},{"issue":"11","key":"2025122907205130600_ref34","first-page":"1359","article-title":"Degradation pathway of ambroxol hydrochloride in fructose infusion","volume":"31","author":"Yu","year":"2014","journal-title":"Chinese Journal of Modern Applied Pharmacy"},{"issue":"4","key":"2025122907205130600_ref35","doi-asserted-by":"crossref","first-page":"463","DOI":"10.1515\/pac-2020-1108","article-title":"Mechanistic studies on the formation of 5-hydroxymethylfurfural from the sugars fructose and glucose","volume":"93","author":"Liu","year":"2021","journal-title":"Pure and Applied Chemistry"},{"key":"2025122907205130600_ref36","doi-asserted-by":"crossref","first-page":"105086","DOI":"10.1016\/j.idairyj.2021.105086","article-title":"Contents and evolution of potential furfural compounds in milk-based formula, ultra-high temperature milk and pasteurised yoghurt","volume":"120","author":"Xing","year":"2021","journal-title":"International Dairy Journal"},{"key":"2025122907205130600_ref37","doi-asserted-by":"crossref","first-page":"133416","DOI":"10.1016\/j.foodchem.2022.133416","article-title":"Maillard reaction chemistry in formation of critical intermediates and flavour compounds and their antioxidant properties","volume":"393","author":"Shakoor","year":"2022","journal-title":"Food Chemistry"}],"container-title":["Journal of Chromatographic Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/chromsci\/article-pdf\/64\/1\/bmaf064\/66144285\/bmaf064.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/chromsci\/article-pdf\/64\/1\/bmaf064\/66144285\/bmaf064.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,29]],"date-time":"2025-12-29T12:21:01Z","timestamp":1767010861000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/chromsci\/article\/doi\/10.1093\/chromsci\/bmaf064\/8406484"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,12,27]]},"references-count":37,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2025,12,27]]}},"URL":"https:\/\/doi.org\/10.1093\/chromsci\/bmaf064","relation":{},"ISSN":["0021-9665","1945-239X"],"issn-type":[{"value":"0021-9665","type":"print"},{"value":"1945-239X","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2026,1]]},"published":{"date-parts":[[2025,12,27]]},"article-number":"bmaf064"}}