采用高效液相色谱法测定左乙拉西坦纯剂型和片剂剂型的含量

Likitha T G, J. Gnana Babu C., S. H G
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引用次数: 0

摘要

建立了一种快速、简便、精确、准确的高效薄层色谱法测定左乙拉西坦原料药和片剂的含量。左乙拉西坦在硅胶60f254高效液相色谱板上作为固定相进行色谱分析。流动相为乙酸乙酯:甲醇:氨,比例为7:1:2。结果表明,左乙拉西坦斑点致密致密,Rf值为0.56。在210 nm处进行定量。从线性度、准确度、精密度、专属性等方面验证了该方法的有效性。统计分析表明,该方法在100 ~ 500 ng/点范围内具有良好的重复性和良好的线性关系。左乙拉西坦的检出限为3.55 ng/点,定量限为10.66 ng/点。该方法可用于片剂型左乙拉西坦的常规分析。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Validated HPTLC method for the quantitation of levetiracetam in pure and tablet dosage form
A rapid, simple, precise and accurate high performance thin layer chromatographic method has been developed and validated for the estima-tion of Levetiracetam in bulk and tablet dosage form. The Levetiracetam was chromatographed on silica gel 60 F254 HPTLC plate as a sta-tionary phase. The mobile phase was Ethyl acetate: Methanol: Ammonia in the ratio of 7:1:2 respectively. It gave a dense and compact spot of Levetiracetam with an Rf value of 0.56. The quantitation was carried out at 210 nm. The method was validated in terms of linearity, accu-racy, precision and specificity. The statistical analysis proved that the developed method is accurate and reproducible with linearity in the range of 100 to 500 ng/spot. The limit of detection and limit of quantitation for Levetiracetam were 3.55 and 10.66 ng/spot respectively. The developed method can be employed for the routine analysis of Levetiracetam in the tablet dosage form.
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