市售硝酸甘油片及注射液的有关物质考察

Determination of related substances in nitroglycerin tablets and nitroglycerin injections by HPLC

目的：建立反相高效液相色谱法（RP—HPLC）测定硝酸甘油片及注射液有关物质的方法。方法：采用Dikma Diamonsil^TM C18（250mm×4．6mm，5μm）色谱柱，乙腈-水（50：50）为流动相，流速1ml／min，检测波长210nm，柱温40℃。结果：硝酸甘油在0．125—6．25μg／ml浓度范围内呈良好的线性关系（r=0．9996，n=6），精密度试验RSD为0．5％（n=5），最低检出量为0．5ng。结论：该方法简便、灵敏、准确，能满足硝酸甘油片及注射液质量控制的要求。

Objective ： To establish a RP - HPLC method for the determination of related substances in nitroglycerin tablets and nitroglycerin injections. Method： Dikma Diamonsil^TM C18 （250 mm × 4.6 mm,5 μm ） column was applied as stationary phase and acetonitrile- water （50： 50） acted as mobile phase. The flow rate of mobile phase was l ml/min and the detection wavelength was at 210 nm under ambient temperature of 40 ℃. Results ： A good linearity was obtained from 0. 125 to 6.25 μg/ml of nitroglycerin （ r = 0. 999 6, n = 6 ） in accompany with RSD of 0.5 % （ n = 5 ）. The LOQ was 0.5 ng. Conclusion ： The method in this paper is simple, sensitive and accurate enough to be employed for the quality control of both nitroglycerin tablets and nitroglycerin injections.