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

作者：Mbinze J K; Dispas A; Lebrun P; Mbay J Mavar Tayey; Habyalimana V; Kalenda N; Rozet E; Hubert Ph; Marini R D^*

来源：Journal of Pharmaceutical and Biomedical Analysis, 2013, 85: 83-92.

DOI：10.1016/j.jpba.2013.06.036

• Antibiotics and associated substances
• Poor quality medicines
• Design of experiments
• Design space
• Method transfer
• Accuracy profile

The poor quality of medicines is a crucial problem of public health. Therefore, it is important to have analytical tools to attend decisions of the legal authorities while combating this offense. In this context, the main objective of this study was to develop generic methods able to trace, screen and determine several antibiotics and common associated molecules by mean of liquid chromatographic techniques. For that purpose, an innovative Design Space optimization strategy was applied, targeting 16 antibiotics and 3 beta-lactamase inhibitors. The robustness of the developed method allowed using its use in an environment where operational factors such as temperature are not easy to control and eased its transfer to Ultra High Performance Liquid Chromatography. To demonstrate its ability to quantify the targeted molecules, the developed and transferred method was fully validated for two active ingredients commonly used in association, sulbactam and ceftriaxone, using the accuracy profile as decision tool. Based on this successful step, the method was then used for the quantitative determination of these two active ingredients in three pharmaceutical brands marketed in the Democratic Republic of Congo. Two out of the three pharmaceutical products did not comply with the specifications.

• 出版日期2013-11