摘要
目的 采用RP -HPLC法测定盐酸西替利嗪的含量及其有关物质。方法 采用ODS色谱柱 (5 μm ,4 .6mm× 15 0mm) ,流动相为乙腈 -水 -冰醋酸 (36∶6 4∶0 .1) ,流速 1.0ml·min-1,检测波长 2 2 9nm ,柱温为室温 (2 5℃ )。结果 盐酸西替利嗪测定的线性范围为 12 .5～ 15 0 μg·ml-1(r=0 .9998,n =6 ) ;日内RSD =0 .36 % (n =5 ) ,日间RSD =0 .6 4 % (n =5 ) ;最低检出限 0 .3ng。结论 所用方法简便、准确 。
OBJECTIVE To establish an RP-HPLC method for the determination of cetirizine hydrochloride and its related substances.METHODS The separation was performed on an ODS column(5 μm,4.6 mm×150 mm).The mobile phase was composed of acetonitrile-water-acetic acid glacial(36∶64∶0.1) with the flowing rate of 1.0 ml·min -1 ,the detection was carried out with a UV detector at 229 nm and the column temperature was room temperature(25℃).RESULTS The calibration curves were linear between 12.5-150 μg·ml -1 ( r = 0.9998 , n =6). RSD of intra-day and inter-day were 0.36%( n =5) and 0.64%( n =5),respectively.The limit of detection was 0.3 ng.CONCLUSION The method is simple,accurate and is suitable for the determination of cetirizine hydrochloride and its related substances.
出处
《华西药学杂志》
CAS
CSCD
2003年第2期131-133,共3页
West China Journal of Pharmaceutical Sciences
