HPLC法同时检测29家硝苯地平制剂的有关物质

HPLC for simultaneous detection of 29 nifedipine-related substances

目的建立一种用高效液相色谱法测定不同厂家硝苯地平片和硝苯地平缓释片有关物质的方法。方法以十八烷基键合硅胶为色谱柱,甲醇-水为流动相进行梯度洗脱,检测波长为235 nm,柱温为30℃。结果不同厂家硝苯地平制剂中存在4个有关物质,分别为杂质A^D,使用该检测方法各杂质均能够达到基线分离,各有关物质的质量浓度在0.1~8.0 mg·L-1内线性关系良好,r≥0.999 0;回收率为97.9%~102.8%(RSD≤1.5%)。结论该方法能够检测29家企业生产的硝苯地平片及硝苯地平缓释片中的有关物质。

Objective To establish an high performance liquid chromatography method for the determination of related substances in nifedipine tablets and nifedipine sustained-release tablets from 29 manufacturers.Methods Related substances in nifedipine was separated on an C18 column with the mobile phase of methanol-water and detected at 235 nm. Column temperature was 30 ℃. Results Impurities A to D were able to achieve baseline separation,and all the related substances were linear within the range of 0. 1-8. 0 mg·L^（-1）,r≥0. 999 0,and the recoveries were 97. 9%-102. 8%（ RSD ≤1. 5%）. Conclusion The method can accurately detect the related substances in 29 manufacturers nifedipine tablets and nifedipine sustained-release tablets with good specificity and high sensitivity.