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目的:建立脉络宁注射液中石斛酚的含量测定方法,以体现所用石斛的质量状况。方法:采用固相萃取小柱净化样品,反相高效液相色谱法分析,C18柱分离,以乙腈-0.05%三氟乙酸溶液(70:30)为流动相,流速1.0 mL.min-1,DAD检测,定量测定波长205 nm。结果:方法回收率98.6%,RSD=2.5%(n=6);重复性RSD=2.1%(n=6);检测限为2.58 ng(S/N=3),定量限为9.16 ng(S/N=10)。所测的79批脉络宁注射液中石斛酚含量在0.200～2.290μg.mL-1,均值0.993μg.mL-1,RSD=45.8%(n=79)。结论:所建立的测定方法准确、可行,可一定程度地反映所用石斛的质量状况。
Objective: To establish a method for the determination of the content of Dendritol in Mailuoning Injection to reflect the quality of Dendrobium used. Methods: The samples were purified by solid-phase extraction cartridges and analyzed by reversed-phase high-performance liquid chromatography with a C18 column. The mobile phase was acetonitrile-0.05% trifluoroacetic acid solution (70:30) DAD detection, quantitative determination of wavelength 205 nm. The detection limit was 2.58 ng (S / N = 3) and the limit of quantification was 9.16 ng (S). Results The recovery rate was 98.6% with a RSD of 2.5% / N = 10). The measured content of ginkgolide in 79 batches of Mailuoning injection was 0.200 ~ 2.290μg.mL-1, with a mean of 0.993μg.mL-1 and RSD = 45.8% (n = 79). Conclusion: The established determination method is accurate and feasible, which can reflect the quality of Dendrobium used to some extent.