Abstract
BackgroundChloroquine and primaquine are the first-line treatment recommended by World Health Organization for malaria caused by Plasmodium vivax. Since the problem of counterfeit or substandard anti-malarials is well established all over the world, the development of rapid and reliable methods for quality control analysis of these drugs is essential. Thus, the aim of this study was to develop and validate a novel UPLC-DAD method for simultaneously quantifying chloroquine and primaquine in tablet formulations.MethodsThe UPLC separation was carried out using a Hypersil C18 column (50 × 2.1 mm id; 1.9 μm particle size) and a mobile phase composed of acetonitrile (A) and 0.1% aqueous triethylamine, pH 3.0 adjusted with phosphoric acid (B), at a flow rate 0.6 mL/min. Gradient elution was employed. UV detection was performed at 260 nm. UPLC method was fully validated and the results were compared to a conventional HPLC-DAD method for the analysis of chloroquine and primaquine in tablet formulations.ResultsUPLC method was shown to be linear (r2 > 0.99), precise (CV < 2.0%), accurate (recovery rates from 98.11 to 99.83%), specific, and robust. No significant differences were observed between the chloroquine and primaquine contents obtained by UPLC and HPLC methods. However, UPLC method promoted faster analyses, better chromatographic performance and lower solvent consumption.ConclusionsThe developed UPLC method was shown to be a rapid and suitable technique to quantify chloroquine and primaquine in pharmaceutical preparations and may be successfully employed for quality control analysis.
Highlights
Chloroquine and primaquine are the first-line treatment recommended by World Health Organization for malaria caused by Plasmodium vivax
Method development Chromatographic parameters employed for the Ultra-performance liquid chromatography (UPLC) method development were initially adapted from HPLC method already used for routine analysis in our laboratory
The retention factor obtained for chloroquine was considerably parameters Chloroquine Primaquine Chloroquine Primaquine
Summary
Chloroquine and primaquine are the first-line treatment recommended by World Health Organization for malaria caused by Plasmodium vivax. Since the problem of counterfeit or substandard anti-malarials is well established all over the world, the development of rapid and reliable methods for quality control analysis of these drugs is essential. Malaria is the world’s most important parasitic infection, ranking among the major health and developmental challenges for the poor countries of the world [1]. According to the World Health Organization, treatment of P. vivax should include an effective schizontocidal medicine, such as chloroquine, combined with a 14-day course of primaquine to prevent relapse (Figure 1) [3,4]. The use of counterfeit and/or substandard anti-malarial drugs can cause increased morbidity and mortality, adverse effects due to excessive dose or the presence
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