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机构地区:[1]广州市药品检验所,广州510160 [2]广东省药品检验所,广州510180 [3]广东药学院,广州510310
出 处:《中国药学杂志》2010年第1期60-63,共4页Chinese Pharmaceutical Journal
摘 要: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 HPLC method for simultaneous determination of tolperisone hydrochloride and methyl hesperidin in Naoluotong Capsules.METHODS The analysis was performed on a shim-pack VP-ODS column(4.6 mm×150 mm,5 μm) with acetonitrile-0.025 mol·L-1 potassium dihydrogen phosphate(add 5 mL triethlamine per litre,and adjusted to pH 3.0 with phosphoric acid)(25∶75).The flow rate was 1.0 mL·min-1.The column temperature was 30 ℃.The detection wavelengths were set at 261 and 283 nm.RESULTS The calibration curves showed good linear response ranged from 0.191 4 to 5.742 μg for tolperisone hydrochloride and from 0.040 5 to 1.215 6 μg for methyl hesperidin.The average recoveries were 101.94%(RSD=1.86%) and 99.68%(RSD=1.01%).CONCLUSION This method was simple,accurate and reliable for the quality control of Naoluotong Capsules.
分 类 号:R917[医药卫生—药物分析学]
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