摘要
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.
出处
《中国药房》
CAS
CSCD
2013年第37期3516-3518,共3页
China Pharmacy