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目的建立测定脑络通胶囊中盐酸托哌酮和甲基橙皮苷的方法。方法采用高效液相色谱法,色谱柱为Shim-pack VP-ODS;乙腈-0.025 mol.L-1磷酸二氢钾(每1 L加5 mL三乙胺,用磷酸调节pH为3.0)(25∶75)为流动相,流速为1.0 mL.min-1;柱温为30℃,检测波长261和283 nm。结果盐酸托哌酮在0.191 4~5.742μm内、甲基橙皮苷在0.040 5~1.215 6μg内呈良好的线性关系,盐酸托哌酮和甲基橙皮苷的平均回收率分别为101.94%和99.68%,RSD为1.86%和1.01%(n=9)。结论所用方法简便、准确,可作为脑络通胶囊的质量控制标准。
Objective To establish a method for the determination of Tropstrolerm and Methyl hesperidin in Naoluotong Capsules. Methods High performance liquid chromatography (HPLC) was performed on Shim-pack VP-ODS column with acetonitrile-0.025 mol·L-1 monobasic potassium phosphate (5 mL triethylamine per 1 L pH adjusted to 3.0 with phosphoric acid) : 75) as the mobile phase at a flow rate of 1.0 mL.min-1. The column temperature was 30 ℃ and the detection wavelength was at 261 and 283 nm. Results Tolperisone hydrochloride showed a good linear relationship in the range of 0.191 4 ~ 5.742μm and 0.0405 ~ 1.215 6μg. The average recoveries of Tolperisone and Methyl hesperidin were 101.94% and 99.68%, RSD 1.86% and 1.01% (n = 9). Conclusion The method is simple and accurate, which can be used as the quality control standard of Naoluotong capsule.