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目的:建立反相高效液相色谱法测定不同批次复方玄驹胶囊中淫羊藿苷含量的方法。方法:采用高效液相色谱法,色谱柱为BDS HYPERSIL C18(250mm×4.6mm,5μm),流动相为甲醇-0.1%磷酸水溶液(58∶42),流速为1.0mL/min,检测波长为270nm,进样量为20μL,柱温为30℃。结果:淫羊藿苷进样0.4995~4.995μg范围内,与峰面积呈良好的线性关系;精密度、稳定性、重复性试验的RSD均小于3%;平均加样收回率为98.2%,RSD为2.19%(n=6)。结论:所建立的方法简便、准确、重复性好,可用于复方玄驹胶囊的质量控制。
OBJECTIVE: To establish a method for the determination of icariin in different batches of Xuanju Capsules by reversed-phase high performance liquid chromatography. Methods: High performance liquid chromatography (HPLC) was performed on a BDS HYPERSIL C18 column (250 mm × 4.6 mm, 5 μm) with a mobile phase of methanol-0.1% phosphoric acid solution (58:42) at a flow rate of 1.0 mL / min and a detection wavelength of 270 nm , Injection volume of 20μL, column temperature of 30 ℃. Results: The icariin injections ranged from 0.4995 to 4.995 μg and showed a good linear relationship with the peak area. The RSDs of precision, stability and repeatability were all less than 3%. The mean recovery rate was 98.2% 2.19% (n = 6). Conclusion: The established method is simple, accurate and reproducible. It can be used for the quality control of Compound Xuanju Capsule.