| 摘要: |
| 目的 建立HPLC-ELSD测定美他多辛注射液有关物质的方法。方法 色谱柱为Agilent Zorbax SB-C18柱(250 mm × 4.6 mm，5 μm)，流动相为0.2 mol·L-1三氟乙酸溶液-甲醇(92∶8)，流速为1.0 mL·min-1，检测器漂移管温度为55 ℃(低温型)，载气压力为420 Pa。结果 主要杂质与美他多辛有较好的分离度，所建立的方法可有效检测无紫外吸收的杂质。结论 方法简单、可靠，适用于美他多辛的质量控制。 |
| 关键词: 高效液相色谱法 美他多辛 有关物质 |
| DOI： |
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| 基金项目: |
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| Determination of the Related Substances in Metadoxine by HPLC-ELSD |
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YANG Weifeng, LIN Yi1,2
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1.Zhejiang Institute for Food and Drug Control, Hangzhou 310004, China;2.Zhejiang Zhenyuan Pharmaceutical Co., Ltd., Shaoxing 312000, China
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| Abstract: |
| OBJECTIVE To establish a method for determination of related substances in metadoxine. METHODS The HPLC-ELSD method was performed on Agilent Zorbax SB-C18 column(250 mm×4.6 mm, 5 μm) with the mobile phase of 0.2 mol·L-1 trifluoroacetic acid-methanol(92∶8), the folw rate was 1.0 mL·min-1 and the drift tube temperature of the detector was 55 ℃(low temperature design), the gas pressure was 420 Pa. RESULTS The main impurities and the metadoxine had a good separation, the established method was effective to detect the non-UV-absorbing impurities. CONCLUSION The method is simple, fast, accurate, and may be used in quality control of metadoxine. |
| Key words: HPLC metadoxine related substances |
