| 高效液相色谱法测定硫酸伏拉帕沙原料药中杂质 |
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| 引用本文： | 孙井龙,毕森,倪冬胜,游凤,赵宜香.高效液相色谱法测定硫酸伏拉帕沙原料药中杂质[J].分析试验室,2021,40(1):44-47. |
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| 作者姓名： | 孙井龙 毕森 倪冬胜 游凤 赵宜香 |
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| 作者单位： | 南京华威医药科技集团有限公司,南京210033;南京华威医药科技集团有限公司,南京210033;南京华威医药科技集团有限公司,南京210033;南京华威医药科技集团有限公司,南京210033;南京华威医药科技集团有限公司,南京210033 |
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| 摘 要： | 建立了高效液相色谱法测定硫酸伏拉帕沙原料药中杂质的方法.采用ACE Excel C18(4.6 mmx 250 mm,5 pm)色谱柱;以pH 2.5的H3PO4溶液为流动相A,乙腈为流动相B,梯度洗脱;检测波长为260 nm;进样量为20 μL.结果表明,主成分与各杂质的分离度良好,各已知杂质在测定的范围内具有良好的...
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| 关 键 词： | 硫酸伏拉帕沙 杂质 高效液相色谱法 |
Determination of related substances in vorapaxar sulfate by RP-HPLC |
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| SUN Jinglong,BI Sen,NI Dongsheng,YOU Feng,ZHAO Yixiang.Determination of related substances in vorapaxar sulfate by RP-HPLC[J].Chinese Journal of Analysis Laboratory,2021,40(1):44-47. |
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| Authors: | SUN Jinglong BI Sen NI Dongsheng YOU Feng ZHAO Yixiang |
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| Institution: | (Nanjing Huawe Medicine Technology Development Co.,LTD.,Nanjing 210033) |
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| Abstract: | A method for the determination of related impurities in vorapaxar sulfate by HPLC was established.ACE Excel C18 column was used.In gradient elution the mobile phase A was water(adjusted to pH 2.5 with phosphoric acid)and mobile phase B was acetonitrile.the detection wavelength was 260 nm and the injection volume was 20μL.The results showed that the main content and the impurities were well separated,and the known impurities had good linearity(r>0.9996)in the determination range.The method can be used for the quality control of volapaxar sulfate. |
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| Keywords: | vorapaxar sulfate related substances HPLC |
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