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Simple LC Isocratic Methods Development, Validation, and Application in the Analysis of Poor Quality Antimalarial Medicines

机译:简单的LC等方法的开发,验证和应用在分析差的质量抗疟药中

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Liquid chromatographic methods in isocratic mode for the analysis of poor quality medicines are privileged due to their simplicity and facility in methods development. They are generally fast; do not need to be re-equilibrated between sample injections; have larger flexibility with acceptable changes on different column dimensions; and are applicable to LC systems equipped with simple or high developed pumps. In this study, we focused on developing simple isocratic methods using classical mobile phase composed by methanol and ammonium formate buffer for the analysis of most common antimalarial medicines marketed in malaria endemic countries and susceptible of being counterfeit/falsified, substandard and degraded. The selected medicines were quinine and related cinchona alkaloids in tablets and injectable forms; artemether/lumefantrine tablets; and artemisinin compounds (arteether, artemether, and artesunate) in injectable forms. The current methods were developed thanks to simple methodological approach consisting in sequential isocratic runs through adjustment or adaptation of existing methods to obtain optimal analytical conditions without complex design of experiments that might be long and costly. Then, the new methods presented shorter analysis time; allowed increase of sample analysis throughput; and obviously consumed little mobile phase solvents on classical analytical columns: 50 - 250 mm of length (L), 4.6 mm of internal diameter (I.D.), and 3.5 - 5.0 μm of particle size (dp).
机译:由于其在方法开发中的简单性和设施,以劣质药物分析的液相色谱方法是特权。它们通常很快;不需要在样品注射之间重新平衡;具有更大的灵活性,在不同的柱尺寸上具有可接受的变化;并且适用于配备简单或高发达泵的LC系统。在这项研究中,我们专注于使用由甲醇和氨基甲酸铵缓冲液组成的经典流动阶段进行简单的等级方法,用于分析疟疾流行国家营销的大多数常见的抗疟药,并且易于伪造/伪造,不合格和退化。所选药物是片剂和可注射形式的奎宁和相关的Cinchona生物碱;蒿甲醚/ Lumefantrine片剂;和青蒿素化合物(艺术家,伪料和artesunate)以可注射形式。由于简单的方法论方法,通过调整或调整现有方法组成的简单方法方法来发展目前的方法,以获得最佳的分析条件,而无需复杂的实验,可能是长期且昂贵的实验。然后,新方法呈现较短的分析时间;允许增加样本分析吞吐量;并且明显消耗了经典分析柱上的小流动相溶剂:50-250 mm长(L),内径4.6毫米(即)和3.5-5.0μm的粒度(DP)。

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