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目的:建立更年灵片中淫羊藿苷、维生素B1及维生素B6的含量测定方法。方法:采用高效液相色谱法,色谱柱为Phe-nomenex C18柱(250mm×4.6mm,5μm)。淫羊藿苷含量测定的流动相为乙腈-水(30:70),流速1.0mL.min-1,在270nm波长处检测;测定维生素B1及B6含量的流动相为甲醇-水(80:20,内含4mmol.L-1十二烷基硫酸钠,用磷酸调节pH至3.5),流速1.5mL.min-1,在275nm波长处检测。结果:淫羊藿苷浓度在18.92～189.20μg.mL-1范围内,与其峰面积呈良好的线性关系(r=0.9999,n=6);平均回收率(n=6)为99.56%。维生素B1和维生素B6浓度分别在10.13～81.06μg.mL-1和10.26～82.04μg.mL-1范围内,与峰面积呈良好的线性关系(r=0.9998和r=0.9999,n=6);平均回收率(n=9)分别为99.96%和99.51%。结论:建立的含量测定方法简便快速,方法可靠,可用于更年灵片的质量控制。
Objective: To establish a method for the determination of icariin, vitamin B1 and vitamin B6 in Geng Ling Ling tablets. Methods: HPLC was used. The column was Phe-nomenex C18 column (250mm×4.6mm, 5μm). The mobile phase for the determination of icariin was acetonitrile-water (30:70) at a flow rate of 1.0 mL.min-1 and was detected at a wavelength of 270 nm; the mobile phase for the determination of vitamin B1 and B6 was methanol-water (80:20). , containing 4mmol.L-1 sodium lauryl sulfate, using phosphoric acid to adjust the pH to 3.5), flow rate 1.5mL.min-1, detection at 275nm wavelength. RESULTS: The icariin concentration ranged from 18.92 to 189.20 μg.mL-1, showing a good linear relationship with its peak area (r=0.9999, n=6); the average recovery rate (n=6) was 99.56%. Vitamin B1 and vitamin B6 concentrations were in the range of 10.13-81.06 μg.mL-1 and 10.26-82.04 μg.mL-1, respectively, showing a good linear relationship with peak area (r=0.9998 and r=0.9999, n=6). The average recovery rate (n=9) was 99.96% and 99.51%, respectively. Conclusion: The established method for determination of content is simple and rapid, and the method is reliable. It can be used for the quality control of Geng Ling Ling tablets.