{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,19]],"date-time":"2026-06-19T01:05:59Z","timestamp":1781831159201,"version":"3.54.5"},"reference-count":27,"publisher":"MDPI AG","issue":"10","license":[{"start":{"date-parts":[[2025,5,13]],"date-time":"2025-05-13T00:00:00Z","timestamp":1747094400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100004040","name":"KU Leuven","doi-asserted-by":"publisher","award":["ZB\/22\/036"],"award-info":[{"award-number":["ZB\/22\/036"]}],"id":[{"id":"10.13039\/501100004040","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Molecules"],"abstract":"<jats:p>The presence of substandard and falsified (SF) medicines poses a significant challenge in resource-limited countries. Low-quality antibiotics are commonly reported in low-income countries. The present study aimed to develop and validate a liquid chromatography method with ultraviolet detection (LC-UV) for the identity screening and assay of 13 different injectable antibiotics, i.e., cefepime, amoxicillin, cefazolin, ampicillin, chloramphenicol, ceftazidime, ceftriaxone, cefotaxime, vancomycin, flucloxacillin, cloxacillin, benzylpenicillin, and meropenem in pharmaceutical formulations. Separation was performed using an XBridge C18 column and gradient elution. Mixtures of acetonitrile and 20 mM phosphate buffer (pH 8.0) were used as the mobile phases. The screening method was validated in terms of specificity and robustness, while linearity, precision, accuracy, and sensitivity were checked for the quantification method. The determination coefficients (R2) following linear regression were all greater than 0.999. The method showed good precision, with relative standard deviation values below 1%. The percentage recovery values were close to 100%. The method was applied to analyze 17 injectable antibiotics collected from the Ethiopian market. All commercial samples analyzed contained the correct API and met USP content specifications.<\/jats:p>","DOI":"10.3390\/molecules30102151","type":"journal-article","created":{"date-parts":[[2025,5,13]],"date-time":"2025-05-13T11:31:49Z","timestamp":1747135909000},"page":"2151","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["A Cost-Effective Liquid Chromatography Method with Ultraviolet Detection for Identity Screening and Assay of Injectable Antibiotics"],"prefix":"10.3390","volume":"30","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7867-0982","authenticated-orcid":false,"given":"Haile Kassahun","family":"Desta","sequence":"first","affiliation":[{"name":"Department of Pharmaceutical and Pharmacological Sciences, Pharmaceutical Analysis, KU Leuven, 3000 Leuven, Belgium"},{"name":"Department of Pharmacy, College of Medicine and Health Sciences, Wollo University, Dessie P.O. Box 1145, Ethiopia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5761-0780","authenticated-orcid":false,"given":"Gebremariam","family":"Ketema","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, College of Medicine and Health Sciences, Wollo University, Dessie P.O. Box 1145, Ethiopia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9583-984X","authenticated-orcid":false,"given":"Ann","family":"Van Schepdael","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical and Pharmacological Sciences, Pharmaceutical Analysis, KU Leuven, 3000 Leuven, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4545-2989","authenticated-orcid":false,"given":"Erwin","family":"Adams","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical and Pharmacological Sciences, Pharmaceutical Analysis, KU Leuven, 3000 Leuven, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,5,13]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"e008587","DOI":"10.1136\/bmjgh-2022-008587","article-title":"Substandard and falsified antibiotics: Neglected drivers of antimicrobial resistance?","volume":"7","author":"Zabala","year":"2022","journal-title":"BMJ Glob. Health"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"2083","DOI":"10.1093\/jac\/dkae177","article-title":"Current practices and challenges of outpatient parenteral antimicrobial therapy: A narrative review","volume":"7","author":"Wolie","year":"2024","journal-title":"J. Antimicrob. Chemother."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"367","DOI":"10.1016\/j.ijantimicag.2015.06.016","article-title":"Assays for therapeutic drug monitoring of \u03b2-lactam antibiotics: A structured review","volume":"46","author":"Carlier","year":"2015","journal-title":"Int. J. Antimicrob. Agents"},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"104053","DOI":"10.1016\/j.microc.2019.104053","article-title":"Fake pharmaceuticals: A review of current analytical approaches","volume":"149","author":"Bottoni","year":"2019","journal-title":"Microchem. J."},{"key":"ref_5","doi-asserted-by":"crossref","unstructured":"Li, H.K., Agweyu, A., English, M., and Bejon, P. (2015). An unsupported preference for intravenous antibiotics. PLoS Med., 12.","DOI":"10.1371\/journal.pmed.1001825"},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"100240","DOI":"10.1016\/j.puhip.2022.100240","article-title":"Falsified and substandard medicines trafficking: A wakeup call for the African continent","volume":"3","author":"Wada","year":"2022","journal-title":"Public Health Pract."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"e181662","DOI":"10.1001\/jamanetworkopen.2018.1662","article-title":"Prevalence and estimated economic burden of substandard and falsified medicines in low-and middle-income countries: A systematic review and meta-analysis","volume":"1","author":"Ozawa","year":"2018","journal-title":"JAMA Netw. Open"},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"60","DOI":"10.1016\/j.trac.2015.11.009","article-title":"Routine quality control of medicines in developing countries: Analytical challenges, regulatory infrastructures and the prevalence of counterfeit medicines in Tanzania","volume":"76","author":"Kaale","year":"2016","journal-title":"TrAC Trends Anal. Chem."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"20552076241299064","DOI":"10.1177\/20552076241299064","article-title":"Quality assessment of medicines in selected resource-limited primary healthcare facilities using low-to medium-cost field testing digital technologies","volume":"10","author":"Opuni","year":"2024","journal-title":"Digit. Health"},{"key":"ref_10","doi-asserted-by":"crossref","unstructured":"Bakker, I.M., Ohana, D., and Venhuis, B.J. (2021). Current challenges in the detection and analysis of falsified medicines. J. Pharm. Biomed. Anal., 197.","DOI":"10.1016\/j.jpba.2021.113948"},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"27550834241236598","DOI":"10.1177\/27550834241236598","article-title":"Improving access to medicines to reduce marketing and use of substandard and falsified medicines in Africa: Scoping review","volume":"8","author":"Sorato","year":"2024","journal-title":"J. Med. Access"},{"key":"ref_12","first-page":"71","article-title":"A systematic review of counterfeit and substandard medicines in field quality surveys","volume":"3","author":"Aslanpour","year":"2014","journal-title":"Integr. Pharm. Res. Pract."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"286","DOI":"10.1016\/j.jpba.2017.05.010","article-title":"Fighting falsified medicines: The analytical approach","volume":"142","author":"Rebiere","year":"2017","journal-title":"J. Pharm. Biomed. Anal."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"218","DOI":"10.1111\/bcp.12298","article-title":"Substandard drugs: A potential crisis for public health","volume":"78","author":"Johnston","year":"2014","journal-title":"Br. J. Clin. Pharmacol."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"443","DOI":"10.1128\/CMR.00072-14","article-title":"Substandard\/counterfeit antimicrobial drugs","volume":"28","author":"Kelesidis","year":"2015","journal-title":"Clin. Microbiol. Rev."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"117666","DOI":"10.1016\/j.trac.2024.117666","article-title":"Stable isotope ratio analysis: An emerging tool to trace the origin of falsified medicines","volume":"174","author":"Roncone","year":"2024","journal-title":"TrAC Trends Anal. Chem."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"175","DOI":"10.1016\/j.jpba.2018.08.037","article-title":"Falsification of biotechnology drugs: Current dangers and\/or future disasters?","volume":"161","author":"Janvier","year":"2018","journal-title":"J. Pharm. Biomed. Anal."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"4727","DOI":"10.1039\/C9AY01489F","article-title":"Detection of degraded, adulterated, and falsified ceftriaxone using paper analytical devices","volume":"11","author":"Bliese","year":"2019","journal-title":"Anal. Methods"},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"23992026211070406","DOI":"10.1177\/23992026211070406","article-title":"Tackling the global impact of substandard and falsified and unregistered\/unlicensed anti-tuberculosis medicines","volume":"6","author":"Akpobolokemi","year":"2022","journal-title":"J. Med. Access"},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"876","DOI":"10.1016\/j.talanta.2018.10.078","article-title":"Development and validation of chromatographic methods for screening and subsequent quantification of suspected illegal antimicrobial drugs encountered on the Belgian market","volume":"194","author":"Tie","year":"2019","journal-title":"Talanta"},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"43","DOI":"10.1186\/s12992-018-0360-y","article-title":"Global landscape assessment of screening technologies for medicine quality assurance: Stakeholder perceptions and practices from ten countries","volume":"14","author":"Roth","year":"2018","journal-title":"Glob. Health"},{"key":"ref_22","unstructured":"World Health Organization (2015). Ethiopian essential medicine list, Food. Medicine and Healthcare Administration and Control Authority of Ethiopia, World Health Organization. [15th ed.]."},{"key":"ref_23","unstructured":"EDQM Council of Europe (2023). European Pharmacopoeia, EDQM Council of Europe. [11th ed.]."},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"83","DOI":"10.1016\/j.jpba.2013.06.036","article-title":"Application of an innovative design space optimization strategy to the development of LC methods for the simultaneous screening of antibiotics to combat poor quality medicines","volume":"85","author":"Mbinze","year":"2013","journal-title":"J. Pharm. Biomed. Anal."},{"key":"ref_25","doi-asserted-by":"crossref","unstructured":"Kassahun, H., Van Schepdael, A., Ketema, G., and Adams, E. (2024). Development and validation of a simple and affordable LC-UV method for identification and assay of selected antimicrobial medicines. J. Pharm. Biomed. Anal., 244.","DOI":"10.1016\/j.jpba.2024.116127"},{"key":"ref_26","unstructured":"US Pharmacopeial Convention (2018). United States Pharmacopeia, USP 41\/The National Formulary, US Pharmacopeial Convention."},{"key":"ref_27","unstructured":"ICH Guidelines (2005). Validation of analytical Procedures: Text and methodology. Q2 (R1), 1, 5."}],"container-title":["Molecules"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/1420-3049\/30\/10\/2151\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,9]],"date-time":"2025-10-09T17:32:10Z","timestamp":1760031130000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/1420-3049\/30\/10\/2151"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,5,13]]},"references-count":27,"journal-issue":{"issue":"10","published-online":{"date-parts":[[2025,5]]}},"alternative-id":["molecules30102151"],"URL":"https:\/\/doi.org\/10.3390\/molecules30102151","relation":{},"ISSN":["1420-3049"],"issn-type":[{"value":"1420-3049","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,5,13]]}}}