Quality Testing of Artemisinin-Based Antimalarial Drugs in Myanmar

Abstract

Artemisinin-based combination therapies are the frontline treatment of malaria. The circulation of falsified and substandard artemisinin-based antimalarials in Southeast Asia has been a major predicament for the malaria elimination campaign. To provide an update of this situation, we purchased 153 artemisinin-containing antimalarials, as convenience samples, in private drug stores from different regions of Myanmar. The quality of these drugs in terms of their artemisinin derivative content was tested using specific dipsticks for these artemisinin derivatives, as point-of-care devices. A subset of these samples was further tested by high-performance liquid chromatography (HPLC). This survey identified that> 35% of the collected drugs were oral artesunate and artemether monotherapies. When tested with the dipsticks, all but one sample passed the assays, indicating that the detected artemisinin derivative content corresponded approximately to the labeled contents. However, one artesunate injection sample was found to contain no active ingredient at all by the dipstick assay and subsequent HPLC analysis. The continued circulation of oral monotherapies and the description, for the first time, of falsified parenteral artesunate provides a worrisome picture of the antimalarial drug quality in Myanmar during the malaria elimination phase, a situation that deserves more oversight from regulatory authorities.

A review on the latest advances in extraction and analysis of artemisinin

“…Most of these analytical techniques or assays for artemisinin ( 1 ) reported until the end of year 2016 have been well documented and appraised in the book published by Tu . However, since then, several modified, and somewhat more precise and fast analytical protocols (Table ), mainly involving various HPLC systems, have been reported in the literature. The following subsections will summarise and appraise those new published protocols.…”

“…Various HPLC methods were previously applied for the qualitative and quantitative determination of artemisinin ( 1 ) in various matrices . and the use of simple HPLC‐UV‐visible method for artemisinin ( 1 ) analysis has continued in recent years …”

“…The lowest artemisinin content was detected in A. dracunculus (0.07%). Guo et al . reported a simple HPLC method for the quality testing of artemisinin ( 1 )‐based antimalarial medications prescribed in Myanmar.…”

“…18 A simple HPLC method was used for the quality testing of artemisinin (1)-based antimalarial medications prescribed in Myanmar. 32 Quantification of artemisinin in the crude extract obtained from supercritical fluid extraction (SFE). 12,13…”

Development of a lateral flow dipstick for simultaneous and semi‐quantitative analysis of dihydroartemisinin and piperaquine in an artemisinin combination therapy

“…5 Our recent surveys in Myanmar also detected the presence of artemisinin monotherapies, substandard ACTs, and even an artesunate drug that contained no active ingredient. 6 As counterfeiting medicines constitute a major threat to global public health, 7 monitoring falsified and substandard ACTs needs to be reinforced in our pursuit of malaria elimination.…”