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

By Isabela da Costa César and Gerson Antônio Pianetti

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 &#956;m), 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 &#956;L. 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 &#956;g/mL and 25 &#956;g/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.<br>A quantificação de artemeter em matéria-prima farmacêutica e solução injetável foi realizada por cromatografia líquida de alta eficiência (CLAE) com detecção na região do ultravioleta. Empregou-se coluna Zorbax C18 (150 x 4.6 mm; 5 &#956;m), mantida a 30 °C, e fase móvel composta por acetonitrila e água (70:30), com fluxo de 1 ml/min. A detecção foi realizada a 216 nm, e o volume de injeção foi 20 &#956;l. O método se mostrou linear (r²=0,9999), preciso (DPR < 2,0% para precisão intra-dia e inter-dias) e seletivo em relação a possíveis impurezas e excipientes das amostras. Os limites de detecção e quantificação obtidos foram 8 &#956;g/mL e 25 &#956;g/mL, respectivamente. O teor médio de artemeter obtido na análise da matéria-prima farmacêutica foi 99,26% e na solução injetável, 102,08%. O método otimizado e validado pode ser utilizado com sucesso para análises rotineiras em controle de qualidade

Topics: Artemeter, Cromatografia líquida de alta eficiência, Antimaláricos, Artemether, High performance liquid chromatography, Antimalarials, Pharmacy and materia medica, RS1-441, Medicine, R, DOAJ:Pharmacy and materia medica, DOAJ:Medicine (General), DOAJ:Health Sciences
Publisher: Universidade de São Paulo
Year: 2009
DOI identifier: 10.1590/S1984-82502009000400018
OAI identifier: oai:doaj.org/article:3f1349741de847c2bfa21995b047a7af
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