脉络宁注射液中石斛酚的含量测定

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0.200~2.290 μg·mL^-1,均值0.993 μg·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 develop a method for analyzing gigantol in Mailuoning injection in order to evaluate the quality of Caulis Dendrobii used in Mailuoning injection. Methods: The samples were cleaned up with SPE,RP-HPLC method and C₁₈ column were used for the analysis,acetonitrile-0.05% trifluoroacetic acid solution(70∶ 30) was used as a mobile phase and DAD as a detector,the flow rate was 1.0 mL·min^-1 and the wavelength for quantification was at 205 nm. Results: The developed method got an average recovery of 98.6%,with RSD of 2.5%(n=6);reproductivity of 2.1% (n=6);LOD(S/N=3) and LOQ(S/N=10) were 2.58 ng and 9.16 ng,respectively.Gigantol in 79 batches of samples was 0.200-2.290 μg·mL^-1,the mean was 0.993 μg·mL^-1,with RSD of 45.8%(n=79). Conclusion: The developed method is accurate and practical,and can reflect to some extent the quality of Caulis Dendrobii used in Mailuoning injection.