Key Points:
·Researchers from KU Leuven (Leuven, Belgium) and Wollo University (Dese, Ethiopia) developed a cost-effective liquid chromatography method with ultraviolet detection (LC-UV method) for identifying and assaying 13 commonly used injectable antibiotics in Ethiopia.
·The method is affordable, uses standard laboratory equipment, and offers strong specificity, sensitivity, and accuracy, making it suitable for routine quality control in low-income countries.
·Applied to 17 market samples, the method confirmed all met United States Pharmacopeia (USP) standards, though some results were close to the lower assay limit of 90%.
A recent study by KU Leuven (Leuven, Belgium) and Wollo University (Dese, Ethiopia)set out to develop an easily applicable liquid chromatographic method with ultraviolet detection (LC-UV) for the identity screening and assay of 13 injectable antibiotics (cefepime, amoxicillin, cefazolin, ampicillin, chloramphenicol, ceftazidime, ceftriaxone, cefotaxime, vancomycin, flucloxacillin, cloxacillin, benzylpenicillin, and meropenem) in pharmaceutical formulations. A paper based on this study was published in Molecules (1).
A leading cause of morbidity and mortality worldwide, bacterial infections especially place greater burdens in low-income and middle-income countries (2–4). Injectable antibiotics are often prescribed for the treatment of severe and life-threatening bacterial infections, and intravenously administered antibiotics are widely used in low-income countries (5,6). Quality assurance of medicines is vital to guarantee medicines reaching patients are safe, effective, and meet acceptable quality standards (7). improving access to good-quality antimicrobial substances, therefore, is critical for ensuring effective treatment, lifesaving therapies, and reducing overall healthcare costs (8—10).
The researchers stated that only a few chromatographic methods have been developed for the screening of antibiotics in pharmaceutical formulations. While Mbinze and associates (11) wrote of an LC method for the analysis of different antibacterial agents, this method has been developed mostly for orally administered antimicrobial medicines, with only two injectable antibiotics (ceftriaxone and cefotaxime) included. Tie and associates (12) optimized an ultrahigh performance liquid chromatography-mass spectrometry (UHPLC-MS) method for the identity screening and a UHPLC–diode array detection method for the quantification of some selected antimicrobial medicines. This method, however, was only applicable to a limited number of injectable antibiotics, including cefepime, cefazolin, ceftazidime, ceftriaxone, cefotaxime, and benzylpenicillin. In addition, these techniques are expensive and may not be easily available in resource-limited countries. Therefore, the researchers set out to address the need for the development and validation of an easy-to-use, accurate, and cost-effective LC-UV method for the quality control of the 13 injectable antibiotics mentioned earlier that have been commonly marketed in Ethiopia (1).
The researchers report that their method demonstrated good specificity, sensitivity, linearity, accuracy, precision, and robustness. The method uses conventional LC-UV equipment, so it is affordable for routine quality control. The availability of a single method for multiple antibiotics, they wrote, is more cost-effective and practical compared to individual methods for each antibiotic. The proposed method was successfully applied to analyze 17 injectable antibiotics collected from the Ethiopian market. All samples complied for identification and met the United States Pharmacopeia (USP) requirements for assay, although several samples were close to the lower limit of 90% (1).
References
1. Desta, H. K.; Ketema, G.; Van Schepdael, A. et al. A Cost-Effective Liquid Chromatography Method with Ultraviolet Detection for Identity Screening and Assay of Injectable Antibiotics. Molecules 2025, 30 (10), 2151. DOI: 10.3390/molecules30102151
2. Zabala, G. A.; Bellingham, K.; Vidhamaly, V. et al. Substandard and Falsified Antibiotics: Neglected Drivers of Antimicrobial Resistance? BMJ Glob. Health. 2022, 7 (8), e008587. DOI: 10.1136/bmjgh-2022-008587
3. Wolie, Z. T.; Roberts, J. A.; Gilchrist, M. et al. Current Practices and Challenges of Outpatient Parenteral Antimicrobial Therapy: A Narrative Review. J. Antimicrob.Chemother. 2024, 79 (9), 2083– 2102. DOI: 10.1093/jac/dkae177
4. Carlier, M.; Stove, V.; Wallis, S. C. et al. Assays for Therapeutic Drug Monitoring of β-lactam Antibiotics: A Structured Review. Int. Journal Antimicrob. Agents 2015, 46 (4), 367–375. DOI: 10.1016/j.ijantimicag.2015.06.016
5. Bottoni, P.; Caroli, S. (2019). Fake Pharmaceuticals: A Review of Current Analytical Approaches. Microchem. J. 2019, 149, 104053. DOI: 10.1016/j.microc.2019.104053
6. Li, H. K.; Agweyu, A.; English, M. et al. An Unsupported Preference for Intravenous Antibiotics. PLoS 2015, 12 (5), e1001825. DOI: 10.1371/journal.pmed.1001825
7. Opuni, K. F.; Sunkwa-Mills, G.; Antwi, M. A. et al. Quality Assessment of Medicines in Selected Resource-Limited Primary Healthcare Facilities Using Low-to Medium-Cost Field Testing Digital Technologies. Digit. Health 2024, 10, 20552076241299064. DOI: 10.1177/20552076241299064
8. Wada, Y. H.; Abdulrahman, A.; Muhammad, M. I. et al. Falsified and Substandard Medicines Trafficking: A Wakeup Call for the African Continent. Public Health Pract. 2022, 3, 100240. DOI: 10.1016/j.puhip.2022.100240
9. Ozawa, S.; Evans, D. R.; Bessias, S. et al. Prevalence and Estimated Economic Burden of Substandard and Falsified Medicines in Low-and Middle-Income Countries: A Systematic Review and Meta-Analysis. JAMA Netw. Open 2018, 1 (4), e181662-e181662. DOI: 10.1001/jamanetworkopen.2018.1662
10. Höllein, L.; Kaale, E.; Mwalwisi, Y. H. et al. Routine Quality Control of Medicines in Developing Countries: Analytical Challenges, Regulatory Infrastructures and the Prevalence of Counterfeit Medicines in Tanzania. TrAC, Trends Anal. Chem. 2016, 76, 60–70. DOI: 10.1016/j.trac.2015.11.009
11. Mbinze, J. K.; Dispas, A.; Lebrun, P. et al. 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. J. Pharm. Biomed. Anal. 2013, 85, 83–92. DOI: 10.1016/j.jpba.2013.06.036
12. Tie, Y.; Vanhee, C.; Deconinck, E. et al. Development and Validation of Chromatographic Methods for Screening and Subsequent Quantification of Suspected Illegal Antimicrobial Drugs Encountered on the Belgian Market. Talanta 2019, 194, 876–887. DOI: 10.1016/j.talanta.2018.10.078
