Development of analytical quality control method of imported antiretroviral drugs

ContributorsEl Morabit, Lamyae
DirectorsRudaz, Serge
Master program titleMaster of Science in Pharmacy
Defense date2020

Human immunodeficiency virus (HIV) infection remains one of the major public health challenges. To eradicate the propagation of HIV by 2030, the World Health Organization promote the antiretroviral therapy. However, most of antiretroviral drugs are still under patent and their high price constitutes a major barrier to their access in low- and middle-income countries. Nonetheless, licenses can be accorded to these countries to produce a lower-cost copy of these patented medicines. Such product would be destined mainly to the internal market. The lack of access to medicines also affects high-income countries like Switzerland. Some vulnerable groups of people such as people living in prison and migrants are not covered by compulsory insurance. In this context, private organizations called Buyers' Clubs were developed in Switzerland to help this population to import unapproved generic drugs. Although imports are made via recognized suppliers based in low- and middle-income countries, these drugs should undergo the quality control. Usually, two complementary approaches were used for quality control: an on-site screening method using rapid tools to assess the drugs quality and a confirmatory method for samples requiring further investigations. Near-infrared spectroscopy (NIRS) is a non-destructive, simple and rapid technique which has recently emerged for the first-line quality control. Separative techniques such as capillary electrophoresis (CE) remain the gold standard for identifying and quantifying drugs. Hence, the main objective of this project was to develop rapid, simple and cost-effectiveness analytical method for the quality control of these unapproved generic antiretroviral drugs. Herein, we show that NIRS offers a great potential as a screening tool because it could be used to discriminate drugs that comes from different suppliers. Moreover, a chemometric technique was proposed to the Buyers' Club to assess the identity and the conformity of drugs. Since the number of samples used in this study were limited, these researches remain a feasibility study, but it could not be used in routine. Thereafter, three CE methods were developed to analyze nine anti-HIV molecules in pharmaceutical formulations. A capillary zone electrophoresis (CZE) method was developed for determination of abacavir, emtricitabine, lamivudine, rilpivirine, tenofovir alafenamide and tenofovir disoproxil. A micellar electrokinetic chromatography method was also developed for efavirenz, emtricitabine and tenofovir disoproxil. Finally, a cyclodextrin-modified capillary electrophoresis method was developed for determination of abacavir, dolutegravir, lamivudine and raltegravir. A CZE method validation was achieved for tenofovir disoproxil and revealed a good repeatability, intermediate precision, linearity and specificity but a poor accuracy. In summary, our results revealed that NIRS offers a great potential as a screening tool. Additionally, three different CE methods were developed for the analyses of the described molecules. Nonetheless, further investigations are required to validate these once in order to implement them to routine applications.

  • HIV
  • Antiretroviral drugs
  • Buyers' Clubs
  • Quality control
  • Near-infrared spectroscopy
  • NIRS
  • Capillary electrophoresis
  • CE
  • CZE
  • MEKC
  • Cyclodextrin
  • Abacavir
  • Dolutegravir
  • Efavirenz
  • Emtricitabine
  • Lamivudine
  • Raltegravir
  • Rilpivirine
  • Tenofovir
Citation (ISO format)
EL MORABIT, Lamyae. Development of analytical quality control method of imported antiretroviral drugs. 2020.
Main files (1)
Master thesis
  • PID : unige:147400

Technical informations

Creation09/19/2020 1:00:00 PM
First validation09/19/2020 1:00:00 PM
Update time03/15/2023 11:52:16 PM
Status update03/15/2023 11:52:16 PM
Last indexation01/29/2024 10:28:38 PM
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