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目的建立HPLC法测定长春西汀氯化钠注射液中长春西汀的含量与有关物质。方法色谱柱为Kromasil C18柱(250 mm×4.6 mm,5μm),流动相为体积分数为0.5%的二乙胺溶液-乙腈-异丙醇(体积比为36∶55∶9),检测波长为280 nm。采用外标法和不加校正因子的主成分自身对照相结合的方法对注射液中的有关物质进行检查,其中杂质A、B、C、D采用外标法,其他未知杂质采用不加校正因子的主成分自身对照法。结果在选定的色谱条件下,长春西汀主峰与有关物质峰基线分离,长春西汀在0.02~0.18 g·L-1内质量浓度与峰面积线性关系良好,高、中、低浓度的回收率分别为99.2%、98.9%和100.3%,相对标准偏差RSD分别为0.54%、0.59%和1.38%(n=3);有关物质的检测结果均在限度范围之内。结论本法可用于长春西汀氯化钠注射液中长春西汀的含量与有关物质的检测。
Objective To establish an HPLC method for the determination of vinpocetine in vinpocetine sodium chloride injection and its related substances. Methods The chromatographic column was Kromasil C18 (250 mm × 4.6 mm, 5 μm). The mobile phase consisted of a 0.5% ethanol solution (acetonitrile / isopropanol) (volume ratio 36:55:9) 280 nm. The external standard method and the main components without correction factor self-control method for the injection of the relevant substances were examined, including impurities A, B, C, D using external standard method, other unknown impurities without correction factor The main component of the self-control method. Results Under the selected chromatographic conditions, the main peak of vinpocetine was separated from the peak of related substances. The linear relationship between the concentration of vinpocetine and the peak area in the range of 0.02 ~ 0.18 g · L-1 was good, with high, medium and low concentrations The relative standard deviations were 0.54%, 0.59% and 1.38%, respectively (n = 3). The detection results of related substances were within the limits. Conclusion This method can be used for the determination of vinpocetine in vinpocetine sodium chloride injection and related substances.