HPLC法测定不同厂家盐酸曲美他嗪原料药及其制剂中的有关物质含量

Content Determination of Related Substances in Trimetazidine Hydrochloride Crude Drug and Its Prepara tions from Different Manufacturers by HPLC

目的：建立能同时检出盐酸曲美他嗪原料药与制剂中有关物质含量的方法。方法：采用高效液相色谱法梯度洗脱法,色谱柱为Thermo Hypersil Gold C18,流动相A为0.287%无水庚烷磺酸钠溶液-甲醇（643∶357,pH 3.0）,流动相B为甲醇,梯度洗脱,流速为1.0 ml/min,检测波长为240 nm。共测定来自7个厂家共22批产品（包括原料药、片剂和胶囊）的有关物质。结果：盐酸曲美他嗪检测质量浓度线性范围为0.4~200.0μg/ml（r=0.999 9,n=6）;精密度（n=5）、重复性（n=6）和稳定性（n=5）试验中RSD≤3.7%。在本色谱系统下,不同产品有关物质检验结果均达到限度要求。结论：本方法结果准确,可用于同时考察盐酸曲美他嗪原料药、片剂和胶囊产品的质量。

OBJECTIVE： To establish a method for simultaneous determination of related substances in crude drug and prepara- tions of trimetazidine hydrochloride. METHODS： HPLC method and gradient elution were adopted. The determination was per- formed on Thermo Hypersil Gold Ct8 column with mobile phase A consisted of 0.287% sodium 1-heptanesulfonate-methanol （643 ： 357, pH 3.0） and mobile phase B consisted of methanol （gradient elution） at the flow rate of 1.0 ml/min. The detection wavelength was set at 240 nm. The contents of related substance were determined in 22 batches of samples （crude drug, tablet and capsule） from 7 manufacturers. RESULTS： The linear range of trimetazidine hydrochloride was 0.4-200.0 lag/ml （r=-0.999 9, n=6）. RSDs of precision （n = 5 ） and repeatability （n=6） and stability （n = 5） tests were all lower than 3,7 %. All the results of samples from dif- ferent manufacturers met the limits under this chromatographic condition. CONCLUSIONS： The established method is accurate and suitable for the quality control of crude dru~, tablet and caosule of trimetazidine hvdrochloride.