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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。
Objective: To study the difference of amoxicillin capsules by different columns. Methods: The column temperature and the detection wavelength were respectively set at 30 ℃, 254 nm and 1.0 ml / min. The mobile phases A and B were 0.05 mol / L phosphate buffer-acetonitrile (99: 1) Buffer - Acetonitrile (80:20). Results: Column 4 had the largest amount of impurities detected in all 4 samples, and columns 1, 2 and 4 had similar maximum amounts of detected impurities in samples A, C, and D3. In column B, column 2 has a smaller maximum detectable amount of impurities and columns 1 and 4 have a similar maximum detectable amount of impurities. The total impurity detected is substantially similar to the detected maximum impurity. Column 4 has the largest total impurity detections and the largest detected impurities peaks in column 4 of the four manufacturers, and column 2 has the lowest total impurity detections. In factory A samples, columns 1, 2 and 4 have similar total impurity detections. In columns C and D, columns 1, 2 and 4 have similar total impurity detections. Samples B and B Column 2 has a smaller total amount of impurities detected, and columns 1 and 4 have similar amounts of total impurities detected. Conclusion: The determination of amoxicillin capsules by different columns have significant differences, and column 3 is the best overall.