HPLC法测定六甲蜜胺有关物质及胶囊剂的含量___
HPLC determination of the content and the related substances in altretamine and altretamine capsules
分类号：
出版年·卷·期（页码）：2010,30 (4):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
-----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，5 μm) 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0.0253~1.517 μg·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12.56~75.35 μg·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。
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-----英文摘要：---------------------------------------------------------------------------------------
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，5 μm) 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 0.0253-1.517 μg·mL-1（r=09999），the detective limit was 0.125 ng（0.025%）；the linear range of the assay was 12.56-75.35 μg·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
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2USP.32：1462
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