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建立了高效液相色谱法测定磷酸特地唑胺中的有关物质。采用Zorbax SB-C_(18)色谱柱,以25 mmol/L碳酸氢铵溶液为流动相A,乙腈为流动相B,线性梯度洗脱(A:0~40 min,95%→10%;40~45 min,10%;45~50 min,10%→95%;50~55 min,95%),检测波长300 nm。在选定的色谱条件下,磷酸特地唑胺与11个已知的有关物质分离良好,有关物质色谱峰与主峰分离度均大于1.5,各有关物质色谱峰之间的分离度均大于2.0。12个化合物在0.1~10μg/ml范围内线性关系良好;有关物质回收率为93.7%~102.3%,RSD为0.27%~0.77%。经方法学验证,本方法可用于磷酸特地唑胺有关物质的检查。
A high performance liquid chromatography was established for the determination of related substances in tetroxamine phosphate. Using a Zorbax SB-C 18 column, the mobile phase A was consisted of 25 mmol / L ammonium bicarbonate solution and acetonitrile as mobile phase B (A: 0-40 min, 95% → 10%; 40 ~ 45 min, 10%; 45-50 min, 10% → 95%; 50-55 min, 95%). The detection wavelength was 300 nm. Under selected chromatographic conditions, the tetrizolate phosphate was well separated from 11 known related substances, and the resolution of the related substances peaks and main peaks were both greater than 1.5, and the separation degrees of all related substances were both greater than 2.0.12 The linearity of the compounds in the range of 0.1 ~ 10μg / ml was good. The recoveries of the related substances ranged from 93.7% to 102.3% with RSDs of 0.27% -0.77%. The methodological verification, the method can be used for the examination of related substances of ternary phosphate phosphate.