关键词：苦参素氯化钠注射液；高效液相色谱法
【摘要】 目的 建立苦参素氯化钠注射液中苦参素含量及有关物质检测的高效液相色谱方法。方法 HypersilC18(5μm，4.6mm×200mm)色谱柱;流动相：三乙胺磷酸缓冲液(pH 7.2)-乙腈(80：20);流速1ml/min，检测波长λ210nm。取三批试药单点外标法测定苦参素含量，归一化法测定制剂中有关物质的含量。结果 苦参素浓度在12～1200μg/ml范围内，峰面积(A)与浓度(C)线性良好，回归方程为(A)=15262759C+24440(r=0.9999)。日内日间RSD< 1%，平均回收率为100.6%。三批样品的含量分别为102.9%、102.4%和102.2%，三批样品有关物质的含量分别为0.31、0.31、0.32。结论 可以应用HPLC测定苦参素氯化钠注射液中苦参素的含量和有关的物质，该方法准确度和精密度高，检测限低，适合应用于该制剂的质量控制。
The study of quality about the injection of kurarinone and sodium chloride
【Abstract】 Objective To use liquid chromatograghy(LC)，and to detect the content of kurarinone and correlative matter in the injection of kurarinone and sodium chloride.Methods Chromatograghic column was Hypersil C18(5μm.4.6mm×200mm);mobile phase were the buffer solution of triethylamine phosphoric acid (pH 7.2);acetenitrile(80：20)，flow rate 1ml/min and detection wavelength was 210nm. To use extiernal standard method，detected the content of kurarinone in the three groups of reagent，detected the content of the correlative matter in the reagent with normalized method. Results We found that the content of kuarinoe was 12～1200μg/ml，peak area(a). concentration(c)and linear regression were favorable， regression equation was A=15262759c+24440(r=0.9999)，and RSD< 1.in a day or next，the everage recovery was 100.6%， the econtent of kurarinone in the three groups of reagent were 102.9%，102.4% and 102.2%，the content of the correlative matter in the three groups of reagent were 0.31，0.31，and 0.32.Conclusion The study shows that we can detect the content of the kurarinone and correlative matter in the injection of kurarinone and sodium chloride with HPLC， The methods has very good accuracy and precision， it is suitable for the quality control of the reagent， with low detection limit.
【摘要】 目的 建立苦参素氯化钠注射液中苦参素含量及有关物质检测的高效液相色谱方法。方法 HypersilC18(5μm，4.6mm×200mm)色谱柱;流动相：三乙胺磷酸缓冲液(pH 7.2)-乙腈(80：20);流速1ml/min，检测波长λ210nm。取三批试药单点外标法测定苦参素含量，归一化法测定制剂中有关物质的含量。结果 苦参素浓度在12～1200μg/ml范围内，峰面积(A)与浓度(C)线性良好，回归方程为(A)=15262759C+24440(r=0.9999)。日内日间RSD< 1%，平均回收率为100.6%。三批样品的含量分别为102.9%、102.4%和102.2%，三批样品有关物质的含量分别为0.31、0.31、0.32。结论 可以应用HPLC测定苦参素氯化钠注射液中苦参素的含量和有关的物质，该方法准确度和精密度高，检测限低，适合应用于该制剂的质量控制。
The study of quality about the injection of kurarinone and sodium chloride
【Abstract】 Objective To use liquid chromatograghy(LC)，and to detect the content of kurarinone and correlative matter in the injection of kurarinone and sodium chloride.Methods Chromatograghic column was Hypersil C18(5μm.4.6mm×200mm);mobile phase were the buffer solution of triethylamine phosphoric acid (pH 7.2);acetenitrile(80：20)，flow rate 1ml/min and detection wavelength was 210nm. To use extiernal standard method，detected the content of kurarinone in the three groups of reagent，detected the content of the correlative matter in the reagent with normalized method. Results We found that the content of kuarinoe was 12～1200μg/ml，peak area(a). concentration(c)and linear regression were favorable， regression equation was A=15262759c+24440(r=0.9999)，and RSD< 1.in a day or next，the everage recovery was 100.6%， the econtent of kurarinone in the three groups of reagent were 102.9%，102.4% and 102.2%，the content of the correlative matter in the three groups of reagent were 0.31，0.31，and 0.32.Conclusion The study shows that we can detect the content of the kurarinone and correlative matter in the injection of kurarinone and sodium chloride with HPLC， The methods has very good accuracy and precision， it is suitable for the quality control of the reagent， with low detection limit.
编辑推荐：
下载Word文档
温馨提示：因考试政策、内容不断变化与调整，长理培训网站提供的以上信息仅供参考，如有异议，请考生以权威部门公布的内容为准！ (责任编辑：长理培训)
点击加载更多评论>>