ABSTRACT
Substandard and falsified (SF) medicines have emerged as a global public health issue within the last two decades especially in low- and middle-income countries (LMICs). Serious consequences of this problem include a loss of trust and increased financial costs due to less disease control and more frequent complications during therapy. Of note, antimicrobial resistance is an additional long-term implication of poor-quality antimicrobials. This review covers information technology tools including medicines authentication tools (MAT) as mobile apps and messaging service, 2D barcoding approaches with drug safety alert systems, web based drug safety alerts, radiofrequency identification tags, databases to support visual inspection, digital aids to enhance the performance of quality evaluation kits, reference libraries for identification of falsified and substandard medicines, and quality evaluation kits based on machine learning for field testing. While being easy to access and simple to use, these initiatives are gaining acceptance in LMICs. Implementing 2D barcoding based on end-to-end verification and "Track and Trace" systems has emerged as a step toward global security in the supply chain. A breakthrough in web-based drug safety alert systems and data bases was the establishment of the Global Surveillance and Monitoring System by the World Health Organization in 2013. Future applications include concepts including "lab on a chip" and "paper analytical devices" and are claimed to be convenient and simple to use as well as affordable. The principles discussed herein are making profound impact in the fight against substandard and falsified medicines, offering cheap and accessible solutions.
ABSTRACT
In this paper, a reliable stability-indicating generic MEEKC method for the analysis of five commonly used fluoroquinolones (FQs) has been developed and optimized by a central composite circumscribed experimental design. The separation was carried out using a fused silica capillary (60.2 cm total length) and a microemulsion (ME) composed of 81.75% (w/w) of a 125 mM NaH2 PO4 solution having a pH of 2.75, 2.65% (w/w) SDS, 1.00% (w/w) n-octanol, 6.60% (w/w) n-butanol and 8.00% (w/w) 2-propanol. A voltage of 28 kV was applied in a reverse polarity mode. A linear relationship was established from 0.04 to 0.48 mg/ml with R2 values higher than 0.98 for all five FQs. Both repeatability and intermediate precision were less than 3% and accuracy ranging from 97 to 100%. Of note, ciprofloxacin impurity A and ofloxacin impurity A could be separated from the respective drug substance in a single run which cannot be achieved using the official HPLC method from the European Pharmacopoeia. Forced degradation of all FQs under heat, in acidic and alkaline medium, in the presence of oxidizing agents and under neutral hydrolysis conditions was investigated. The highest yield of degradation products was observed using oxidative hydrogen peroxide. Hence, the proposed MEEKC method can be used for the quantitative determination of the five FQs and their potential impurities within a total runtime of 20 min.
