| 李姮,耿颖.基于X-Charge色谱柱的HPLC法测定卡巴胂原料药含量和有关物质[J].中国药品标准,2017,18(1):34-36 |
| 基于X-Charge色谱柱的HPLC法测定卡巴胂原料药含量和有关物质 |
| Determination of Assay and Related substances of drug substance of Carbarsone by X-Charge column-based HPLC methods |
| 投稿时间：2016-09-13 修订日期：2017-01-16 |
| DOI： |
| 中文关键词: 卡巴胂 有关物质 含量测定 高效液相色谱法 |
| 英文关键词: Carbarsone related substance assay HPLC method |
| 基金项目:中检院青年基金 2014A8 基于质谱技术的快速检测方法对普利类药物进行手性识别的研究 |
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| 中文摘要: |
| 目的：建立卡巴胂原料药有关物质检查和含量测定的高效液相色谱方法。方法： 色谱柱为Acchrom Xcharge C18柱，流动相为0.1%三氟乙酸溶液-0.1%三氟乙酸乙腈溶液，梯度洗脱，流量1.0ml?min-1，检测波长254nm，柱温30℃。结果：该方法的专属性、准确度、精密度、线性、范围、检测限及定量限均可满足卡巴胂原料药有关物质检查和含量测定的需要。结论：所建方法简便、准确，可用于卡巴胂原料药有关物质检查和含量测定。 |
| 英文摘要: |
| Objective： To establish an HPLC method for the determination of assay and related substances of drug substance of carbarsone．Methods： The analysis was performed by HPLC with Acchrom X-charge C18 column and a gradient elution of mobile phase of 0.1% trifluoroacetic acid solution and 0.1% trifluoroacetic acid acetonitrile solution, a flow rate at 1.0 ml?min-1, the detection wavelength as 254 nm and column temperature as 30℃．Results: The specificity, accuracy, precision, linearity, range, limit of detection and limit of quantitation met the methodology requirements on assay and related substances of drug substance of carbarsone. Conclusion：The method is simple and accurate which can be used for the determination of related substances and assay of drug substance of carbarsone. |
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