蒿甲醚的稳定性指示高效液相色谱法及其在蒿甲醚纳米粒中的应用
Stability-indicating HPLC method for arteether and application to nanoparticles of arteether.
作者信息
Gugulothu Dalapathi, Patravale Vandana
机构信息
Department of Pharmaceutical Sciences and Technology, Institute of Chemical Technology, N.P. Marg, Matunga, Mumbai 400019, India.
Department of Pharmaceutical Sciences and Technology, Institute of Chemical Technology, N.P. Marg, Matunga, Mumbai 400019, India
出版信息
J Chromatogr Sci. 2014 Sep;52(8):831-6. doi: 10.1093/chromsci/bmt125. Epub 2013 Aug 26.
A simple, precise, isocratic, reverse-phase high-performance liquid chromatography method was developed for the rapid determination of arteether using an Agilent RP C18, 4.6 × 150 mm, 5 μm XDB column. The runtime was 9 min. The effect of flow rate, injection volume and mobile phase composition on resolution was investigated. The analytical procedures of the method were validated with respect to precision, accuracy and linearity according to the International Conference on Harmonization guidelines. The limit of detection and the limit of quantitation were 3.3 and 10.0 μg/mL, respectively. Linearity range was from 10.00 to 500 μg/mL. Further, the proposed method was found to be reproducible and convenient for stability-indicating analysis of arteether as a bulk drug and from nanoparticulate formulation.
开发了一种简单、精确、等度反相高效液相色谱法，用于使用安捷伦RP C18（4.6×150 mm，5μm XDB柱）快速测定蒿乙醚。运行时间为9分钟。研究了流速、进样体积和流动相组成对分离度的影响。根据国际协调会议指南，对该方法的分析程序进行了精密度、准确度和线性验证。检测限和定量限分别为3.3和10.0μg/mL。线性范围为10.00至500μg/mL。此外，该方法被发现可重现且便于对蒿乙醚原料药和纳米颗粒制剂进行稳定性指示分析。
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