| 乔乔,余小红,陈斌,等.高效液相色谱法测定琥珀酸多西拉敏片中有关物质[J].安徽医药,2020,24(10):1958-1961. |
| 高效液相色谱法测定琥珀酸多西拉敏片中有关物质 |
| Determination of related substances in doxylamine succinate tablets by HPLC |
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| DOI：10.3969/j.issn.1009?6469.2020.10.010 |
| 中文关键词: 多西拉敏/分析 色谱法，高压液相 药物污染 回收率 |
| 英文关键词: Doxylamine/analysis Chromatography,high pressure liquid Drug contamination Retrieving rate |
| 基金项目:合肥市2018年省战略性新兴产业集聚发展基地研发类项目(11) |
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| 中文摘要: |
| 目的建立高效液相色谱法(HPLC)法测定琥珀酸多西拉敏片中的有关物质。方法 2017年 10月至 2018年 9月，采用高效液相色谱法，紫外检测器，苯基硅烷键合硅胶柱，固定相: Polar?Phenyl，250 mm×4.6 mm，5 μm，流动相: 0.01 mol/L磷酸二氢钾溶液(加三乙胺溶液 3 mL，用磷酸调节 pH至 3.0)?乙腈(89∶11)，检测波长: 260 nm。结果 5种已知杂质和琥珀酸多西拉敏及其他未知杂质均能得到有效分离；琥珀酸多西拉敏、杂质 A、B、C、E和 G分别在 0.08～20.36、0.08～20.14、0.05～19.85、0.10～ 20.66、0.25～20.39、0.05～22.63 μg/mL范围内线性关系良好， r均为 0.999 9。杂质 A、B、C、E和 G平均回收率分别为 99.62%，98.87%，1 |
| 英文摘要: |
| Objective To establish a HPLC method for determining the related substances in doxylamine succinate tablets.Meth? ods High performance liquid chromatography，ultraviolet detector and phenylsilane bonded silica gel column were used from Octo?ber 2017 to September 2018.Stationary phase was Polar?Phenyl(250 mm×4.6 mm，5 μm)，mobile phase consisted water of 0.01mol· L?1 potassium dihydrogen phosphate(add 3mL of triethylamine and adjusted pH to 3.0 with phosphoric acid)?acetonitrile(89∶11). The detective wavelength was set at 260nm.Results Doxylamine succinate and its five related substances(impurity A，B，C，E and G)were determinated by HPLC，in which the linearity were good within the range 0.08?20.36，0.08?20.14，0.05?19.85，0.10?20.66，0.25?20.39 and 0.05?22.63 μg/mL，and the regression coefficient were all 0.999 9，respectively，while the recoveries of the five relat? ed substances were 99.62%，98.87%，101.68%，102.85% and 100.41%.Conclusion This method was operated easily，and it can be used to accurately determinate the related substances contend in doxylamine succinate tablets. |
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