不同色谱柱测定阿莫西林胶囊有关物质的差异性研究

摘要

Objective To study the differences of Amoxicillin related substances between different columns. Methods Column, detection wavelength, the flow rate were 30 ℃, 254nm, 1.0 mL / min, mobile phase A, B were 0.05 mol / L phosphate buffer -acetonitrile (99:1), 0.05 mol / L phosphate buffer solution - acetonitrile (80:20), respectively. Results In 4 samples fac-tories, columns 3 had maximum detectable amount of impurities, and in A, C, D3 factories samples, column 1,2,4 impurities had similar maximum detectable amount, in B Manufacturers sample, column 2 had smaller maximum detectable amount of maga-zines, columns 1,4 had similar maximum impurity detection limit; total impurities in detection of maximum impurity detection substantially similar situation. In 4 factories samples, column 3 had the largest and most detectable amount of total impurities of impurity peaks were detected, column 2 had the smallest detectable amount of total impurities. A factory in the sample, columns 1,2,4 had similar total impurity detectable amount, in C, D manufacturers sample, columns 1,2,4 had similar amount of total im-purities detected in the sample B factory in column 2 had smaller amount of total impurities detected, columns 1,4 had similar amount of total impurities detected. Conclusion Different columns have greater difference in the detection of amoxicillin related substances, on the whole, the best is column 3.%目的：研究不同色谱柱测定阿莫西林胶囊有关物质的差异性。方法：柱温、检测波长、流速分别为30℃、254nm、1.0ml/min，流动相 A、B 分别为0.05 mol / L 磷酸盐缓冲液－乙腈（99：1）、0.05 mol / L 磷酸盐缓冲液－乙腈（80：20）。结果：在4个厂家样品中，色谱柱3均具有最大的杂质检出量，而在 A、C、D3个厂家样品中，色谱柱1、2、4具有相似的最大杂质检出量，在 B 厂家样品中，色谱柱2具有较小的最大杂质检出量，色谱柱1、4则具有相似的最大杂质检出量；总杂质的检出情况基本类似于最大杂质的检出情况。在4个厂家样品中，色谱柱3具有最大的总杂质检出量和最多的检出杂质峰，色谱柱2具有最小的总杂质检出量。在 A 厂家样品中，色谱柱1、2、4具有相似的总杂质检出量，在 C、D 厂家样品中，色谱柱1、2、4具有相似的总杂质检出量，在 B 厂家样品中，色谱柱2具有较小的总杂质检出量，色谱柱1、4具有相似的总杂质检出量。结论：不同色谱柱测定阿莫西林胶囊有关物质具有较大的差异，从总体上来看，色谱柱3最好。