Quantitation of artemether in pharmaceutical raw material and injections by high performance liquid chromatography

Isabela Da Costa César,Gerson Antônio Pianetti

doi:10.1590/s1984-82502009000400018

Abstract

The quantitation of artemether in both pharmaceutical raw material and injections was carried out by high performance liquid chromatography (HPLC) with ultraviolet detection. A Zorbax C18 column (150 x 4.6 mm; 5 μm), at 30 °C, and a mobile phase composed of acetonitrile and water (70:30), at a flow rate of 1ml/min, were used. The detection wavelength was 216 nm and the injection volume was 20 μL. The method proved to be linear (r²=0.9999), precise (RSD < 20% for intra-day and inter-day precision), accurate and selective regarding possible impurities and excipients of the samples. The detection and quantitation limits were 8 μg/mL and 25 μg/mL, respectively. The artemether content obtained in the raw material analysis was 99.26% and in the injections, 102.08%. The optimized and validated method may be successfully employed to perform routine quality control analyses.

Highlights

Malaria is the world’s most important parasitic infection and effective control of this disease poses a great challenge to the public health sector in poor countries (Guerin et al, 2002)
Artemether can be associated with lumefantrine, in fixed-dose combination tablets containing 20 mg of artemether and 120 mg of lumefantrine, as a first-line therapy in the treatment of falciparum malaria in Brazil (Brasil, 2006)
The artemether spectrum in the ultraviolet region was obtained in the range of 200 to 400 nm using the diode array detector (DAD) of the chromatograph with a solution at 4 mg/mL in the mobile phase

Summary

Introduction

Malaria is the world’s most important parasitic infection and effective control of this disease poses a great challenge to the public health sector in poor countries (Guerin et al, 2002). The incidence of malaria worldwide is estimated to be 300-500 million clinical cases each year, with around 90% of these occurring in Africa, mostly caused by Plasmodium falciparum. Malaria is thought to kill between 1.1 and 2.7 million people worldwide each year, about one million of whom are African children under the Artemether, called dihydroartemisinin methyl ether (Figure 1), is a synthetic derivative of artemisinin, widely used in malaria treatment in endemic areas. This drug can be administered as an oily solution by intramuscular injection, or in tablets orally (Karbwang et al, 1997).

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