【摘要】 目的:建立了HPLC法测定六甲蜜胺有关物质及胶囊剂的含量。方法:采用Agilent 1100型高效液相色谱仪,色谱柱为Kromasil C₁₈（4.6 mm×250 mm,5μm）柱,流动相为甲醇-碳酸铵溶液[取碳酸铵0.79 g,加水1000 mL使溶解,用甲酸溶液（1→10）或氨水溶液（1→10）调节pH至8.0±0.05]（75:25）,流速1.0 mL·min^-1,检测波长227 nm,柱温:40℃。结果:六甲蜜胺有关物质线性范围为0.0253～1.517μg·mL^-1（r=0.9999）,杂质限度范围为0.05%～3.0%,最低检测限为0.125 ng（0.025%）;六甲蜜胺胶囊含量测定线性范围为12.56～75.35μg·mL^-1（r=0.9998）,平均回收率为99.8%,RSD=0.7%（n=9）。结论:该方法准确、灵敏、重现性好,专属性强,可用于六甲蜜胺及其胶囊的质量控制。更多还原

【Abstract】 Objective:To establish an HPLC method for the analysis of the content and the related substances in altretamine capsules and altretamine.Method:The HPLC method was performed on an Agilent 1100 liquid chromatography. Kromasil C₁₈ column（4.6 mm×250 mm,5μm） was adopted with the mobile phase of methanol - ammonium carbonate solute[adjusted pH to 8.0±0.05 by formic acid solution（1→10） or ammonia solution（1→10）] （75:25）.The flow rate was 1.0 mL·min^-1 and the detection wavelength was set at 227 nm.The Column temperature was set at 40℃.Results:The linear range of the related substances was 0.0253 - 1.517μg·mL^-1（r = 0.9999）,the detective limit was 0.125 ng（0.025%）;the linear range of the assay was 12.56 -75.35μg·mL^-1 （r = 0.9998）,the average recovery（n = 9） was 99.8%and RSD was 0.7%.Conclusion:The method is accurate, specific,sensitive and can be used for quality control of altretamine and altretamine capsules.更多还原