An LC method for the simultaneous screening of some common counterfeit and sub-standard antibiotics Validation and uncertainty estimation.

J Pharm Biomed Anal

Dipartimento del Farmaco, Istituto Superiore di Sanità Viale Regina Elena, 299, 00161, Rome, Italy.

Published: September 2008

Pharmaceutical counterfeiting is a worldwide public health problem, often under-recognised, especially in developing countries where the percentage of counterfeit and sub-standard medicines is dramatically high. Antibiotics, among the most widespread drugs, have been particularly targeted by counterfeiters. World Health Organization emphasizes the need for development and distribution of screening methods explicitly targeted to counterfeit drugs. In this paper is presented a single method for the simultaneous analysis of some of the most common and counterfeited essential antibiotics: ampicillin, amoxicillin+clavulanic acid, doxycycline, cloxacillin, chloramphenicol. A full validation was performed in terms of linearity, precision, robustness and trueness; an assessment of uncertainty was carried out exploiting these data. A wide linearity range was investigated considering the specific nature of counterfeit and sub-standard drugs, whose content in active substance may be rather far from the declared amount. A large span in robustness parameters was considered and a complete intermediate precision assessment was conducted, envisaging the possibility of transferring the method to quality control laboratories, hopefully in developing countries. Finally, the method was successfully applied to the analysis of antibiotics purchased on the informal market in Chad, among which counterfeit and sub-standard samples were detected.

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jpba.2007.12.032DOI Listing

Publication Analysis

Top Keywords

counterfeit sub-standard
16
method simultaneous
8
developing countries
8
counterfeit
5
method
4
simultaneous screening
4
screening common
4
common counterfeit
4
sub-standard
4
antibiotics
4

Similar Publications

The African continent is home to 15% of the world's population and suffers from a disease burden of more than 25% globally. In this COVID-19 era, the high burden and mortality are further worsened due to inequities, inequalities such as inadequate health systems, scarce financial and human resources, as well as unavailability of inexpensive medicines of good quality, safety, and efficacy. The Universal Health Coverage ensures that people have access to high-quality essential health services, secure, reliable, and affordable essential medicines and vaccines, as well as financial security.

View Article and Find Full Text PDF

Background: Infections caused by extended-spectrum beta-lactamases (ESBL) producing Gram-negative bacteria has emerge as a global threat in clinical practices. The treat is more serious in developing countries due to inappropriate use, poor adherence, use of counterfeit, sub-standard antibiotics and poor infection control practices. Data on ESBL producing Gram-negative bacteria are limited in developing countries including Ethiopia.

View Article and Find Full Text PDF
Article Synopsis
  • Malaria control efforts are significantly supported by the Global Fund, US President's Malaria Initiative, and the World Bank, focusing on funding drug safety and pharmacovigilance to combat drug resistance.
  • An analysis of malaria grants from these organizations reveals that as of September 2015, a total of 159 active grants were identified, with a notable portion directed toward low-income countries and sub-Saharan Africa.
  • Out of these grants, only about 23% included specific budget allocations for pharmacovigilance and drug quality assurance activities, highlighting a gap in addressing drug safety concerns in malaria interventions.
View Article and Find Full Text PDF

Background: Malaria is one of the most lethal and life-threatening infectious diseases in the world, causing more than half a million deaths annually. Treatment with mefloquine and artesunate is currently recommended by the World Health Organization, and was historically the first artemisinin-based combination therapy used clinically for treatment of Plasmodium falciparum. The problem of poor-quality medicines, such as counterfeit and sub-standard anti-malarials, is a worldwide issue; therefore, it is essential to develop rapid, low cost, solvent-free, and reliable methods for routine quality control for these drugs.

View Article and Find Full Text PDF

African animal trypanosomosis is arguably the most important animal disease impairing livestock agricultural development in sub-Saharan Africa. In addition to vector control, the use oftrypanocidal drugs is important in controlling the impact of the disease on animal health and production in most sub-Saharan countries. However, there are no internationally agreed standards (pharmacopoeia-type monographs or documented product specifications) for the quality control of these compounds.

View Article and Find Full Text PDF

Want AI Summaries of new PubMed Abstracts delivered to your In-box?

Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!