HPLC法测定马洛替酯片的含量及有关物质

Determination of the Content of Malotilate Tablets and Related Substances by HPLC

目的：建立测定马洛替酯片的含量及有关物质的方法。方法：采用高效液相色谱法。色谱柱为Waters Symmetry-C18,流动相为甲醇-水-醋酸（45∶55∶0.5,V/V/V）,检测波长为362 nm,流速为1.0 ml/min,柱温为30℃,进样量为20μl。结果：主成分峰与杂质峰均能达到基线分离;马洛替酯质量浓度在1.50~30.0μg/ml范围内与峰面积呈良好的线性关系（r=0.999 6）;精密度、稳定性、重复性试验的RSD≤1.05%;平均加样回收率为99.74%,RSD=0.85%（n=9）。结论：本法简便、准确、专属性好、精密度高,可用于马洛替酯片的质量控制。

OBJECTIVE：To establish a method of the content and related substances determination of Malotilate tablets.METHODS：HPLC was performed on the column of Waters Symmetry-C18 with mobile phase of methanol-water-acetic acid（45∶55∶0.5,V/V/V）at the flow rate of 1.0 ml/min,the detection wavelength was 362 nm,the column temperature was 30 ℃ and the volume was 20 μl.RESULTS：The main component peak and impurity peak could be baseline separated;there was a good linear relationship between the mass concentration of malotilate and peak area in the range of 1.50-30.0 μg/ml（r=0.999 6）;the RSDs of precision,stability and reproducibility tests were no more than 1.05%;the average recovery was 99.74%（RSD=0.85%,n=9）.CONCLUSIONS：The method is simple,accurate,specific and precise,and can be used for quality control of Malotilate tablets.