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用差分脉冲极谱法测定药物制剂中的抗疟药物蒿甲醚。

Determination of the antimalaria drug artemether in pharmaceutical preparations by differential pulse polarography.

作者信息

Debnath C, Haslinger E, Likussar W, Michelitsch A

机构信息

Institute of Pharmaceutical Sciences, University Graz, Schubertstrasse 1, A-8010 Graz, Austria.

出版信息

J Pharm Biomed Anal. 2006 May 3;41(2):638-43. doi: 10.1016/j.jpba.2005.12.003. Epub 2006 Jan 18.

Abstract

A differential pulse polarographic method has been developed for the determination of artemether in its pharmaceutical formulations. The polarographic behaviour of artemether was examined in various buffer systems over the pH range 3.0-10.0. In phosphate buffer pH 5.5/methanol solution (7:3, v/v) the differential pulse polarograms displayed reproducible peaks at Ep-0.01 V versus Ag/AgCl. Under these conditions strict linearity between artemether concentration and peak height was observed in 3.4x10(-7)-3.0x10(-5)mol/L concentration range (R=0.9998). The detection limit was calculated to be 32 ng/mL. The polarographic method was applied to the determination of the content of artemether in tablets and capsules by using the standard addition method. The analysis of tablets containing 20mg artemether showed a mean value of 19.73 mg with a relative standard deviation (R.S.D.) of +/-1.01%. A content of 39.74 mg artemether was found in 40 mg capsules with a relative standard deviation of +/-0.53%. The polarographic method is characterised to be cheap, precise and not time-consuming and can therefore be used for routine analysis of artemether in its pharmaceutical preparations.

摘要

已开发出一种差分脉冲极谱法用于测定蒿甲醚药物制剂中的蒿甲醚含量。在pH值为3.0至10.0的各种缓冲体系中研究了蒿甲醚的极谱行为。在pH 5.5的磷酸盐缓冲液/甲醇溶液(7:3,v/v)中,差分脉冲极谱图在相对于Ag/AgCl为Ep - 0.01 V处显示出可重现的峰。在此条件下,在3.4×10⁻⁷ - 3.0×10⁻⁵mol/L浓度范围内观察到蒿甲醚浓度与峰高之间具有严格的线性关系(R = 0.9998)。计算得出检测限为32 ng/mL。采用标准加入法将极谱法应用于片剂和胶囊中蒿甲醚含量的测定。对含20mg蒿甲醚的片剂分析显示平均值为19.73mg,相对标准偏差(R.S.D.)为±1.01%。在40mg胶囊中发现蒿甲醚含量为39.74mg,相对标准偏差为±0.53%。该极谱法的特点是成本低、精确且不耗时,因此可用于蒿甲醚药物制剂的常规分析。

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