Development and validation of HPLC methods for simultaneous analysis of 6 antiretrovirals in pharmaceutical formulations

Abstract

HIV/AIDS is one the world’s most serious public health problems and affects an important number of populations in Africa; particularly in the Democratic Republic of the Congo (DRC) where the access to a good antiretrovirals (ARVs) treatment remains a big issue. To increase the life quality of people living with HIV/AIDS, it is urgent to secure medicines of good quality and in good quantity for everyone in need. The drugs efficiency and safety depend first on their quality, and secondly on their use.1 In the particular case of DRC, we estimated that among one million people living with HIV/AIDS2 only 350,000 were having ARV treatment in 2011-2015. This number, decreased only in 44 000 patients who were effectively treated with ARVs,3 which represented a coverage of 14 % ARV treatment. This was the lowest rate in the world and shows that more than 300 000 people were in need but were not served.4 Nowadays, one can tell that the situation remains unchanged and there is an emergency for the HIV/AIDS living people. In addition to poor accessibility to ARV treatment, another important question may arise from the ARV products, and this concerns their quality! Antiretrovirals are medicines used to treat the HIV infection. They act by reducing the viral DNA replication speed, stopping at the same time its propagation in the body5. Since the launch of Monetary Found and Medicines Access Program projects, the ARV treatment is given to the public for free, but their access stills a problem in some countries. This is unfortunately the case of the DRC, where the national guide of HIV treatment was elaborated in 2003 and reviewed in 2005, 2008 and 2010, following the new recommendations of WHO.6,7 For importer countries, it is very important to certify the ARV quality according to the national guidelines and the manufacturer data submitted to the public health authorities before their launch in the market for use.8