HPLC法同时测定吲达帕胺中11种有关物质的含量

Simultaneous determination of the eleven related substances in indapamide by high performance liquid chromatography

目的建立吲达帕胺缓释片中有关物质检测方法。方法采用高效液相色谱法测定,色谱柱以辛烷基键合硅胶为填充剂(250 mm×4.6 mm,5μm);10 mmol·L^(-1)乙酸铵溶液(用冰乙酸调节pH至5.0)为流动相A,乙腈为流动相B进行梯度洗脱;流速为1.0 mL·min^(-1);检测波长为242 nm,柱温为30℃。结果吲达帕胺色谱峰与各已知杂质及未知杂质色谱峰均达到有效分离,分离度符合要求,其中各已知杂质的质量浓度与峰面积呈良好的线性关系,回收率在94%~103%内。结论该方法适用于该制剂有关物质的控制。

Objective To establish a method for detecting related substances in indapamide sustained-release tablets.Methods The related substances were determined by high-performance liquid chromatography.The column was filled with octyl-bonded silica gel(250 mm×4.6 mm,5μm).Ammonium acetate solution(10 mmol·L^(-1),the pH was adjusted to 5.0 with glacial acetic acid)was used as mobile phase A,with acetonitrile as mobile phase B.Flow rate was 1.0 mL·min^(-1) with gradient elution.Detection wavelength was 242 nm.The column temperature was 30℃.Results The indapamide peak was effectively separated from the known and unknown impurity peaks,and the resolution met the requirements.The concentration of each known impurity and the peak area were linear and the recovery rate was in the range of 94%-103%.Conclusion The method is suitable for the control of related substances in indapamide sustained-release tablets.