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目的:建立理气舒心片中橙皮苷、柚皮苷的反相高效液相色谱(RP-HPLC)含量测定方法,进一步提高理气舒心片的质量标准。方法:采用Sunfire C_(18)色谱柱(4.6mm×250mm,5μm),以甲醇-2%冰醋酸溶液(30∶70)为流动相,流速1.0mL·min~(-1),检测波长284nm,柱温30℃,进样量10μL。结果:柚皮苷和橙皮苷的线性范围分别为5.72~286.0μg·mL~(-1)、4.856~242.8μg·mL~(-1);回收率分别为97.1%(RSD=1.2%)、103.2%(RSD=1.1%)。不同厂家理气舒心片中柚皮苷、橙皮苷的含量差别很大,含量范围为0.198~2.670mg·g~(-1)、0.800~3.123mg·g~(-1)。结论:该方法经方法学验证,可用于理气舒心片中橙皮苷、柚皮苷含量的测定,可为理气舒心片的质量标准改进提供参考,有效控制其质量。
Objective: To establish a RP-HPLC method for the determination of hesperidin and naringin in Liqi Shuxin tablets and to further improve the quality standard of Liqi Shuxin Tablet. Methods: The mobile phase consisted of Sunfire C 18 column (4.6 mm × 250 mm, 5 μm) and methanol-2% acetic acid solution (30:70) at a flow rate of 1.0 mL · min -1 with a detection wavelength of 284 nm , Column temperature 30 ℃, injection volume 10μL. Results: The linear ranges of naringin and hesperidin were 5.72 ~ 286.0 μg · mL -1 and 4.856 ~ 242.8 μg · mL -1, respectively. The recoveries were 97.1% (RSD = 1.2%), , 103.2% (RSD = 1.1%). The content of naringin and hesperidin varies greatly in different manufacturers’ qi-qi tablets, ranging from 0.198 ~ 2.670mg · g -1, 0.800 ~ 3.123mg · g -1. Conclusion: This method is validated by method and can be used to determine the content of hesperidin and naringin in Liqi Shuxin Tablet, which can provide reference for improving the quality standard of Liqi Shuxin Tablet and effectively control its quality.