摘要
目的建立HPLC法测定盐酸异丙嗪注射液有关物质含量。方法采用反相高效液相色谱法：色谱柱为SHIMADEUVp-C18柱,甲醇-水（用冰醋酸调节pH值为2.25±0.05）（体积比49∶51）为流动相,流速：0.8mL·min^-1,柱温：30℃,检测波长为254 nm。结果在正常贮藏条件下,11批样品的杂质总量均在0.4%-0.6%之间,定量限小于0.5μg。结论本法可用于盐酸异丙嗪注射液中有关物质的含量测定。
Objective To establish a HPLC method to determine related substance in promethazine hydrochloride injection.Method The HPLC was carried out on a C18 column,of which the mobile phase was consisted of water（adjusted to pH 2.25±0.05 by acetate） and methanol（51∶49）.The detective wavelength was 254 nm.Results The contents of 11 samples were above 0.4%,and below 0.6% under normal store conditions.The limit of quantification was under 0.5 μg.Conclusion It is simple,accurate and feasible for determining related substance in promethazine hydrochloride injection by HPLC.
出处
《广东药学院学报》
CAS
2009年第6期592-595,共4页
Academic Journal of Guangdong College of Pharmacy
作者简介
宋新康（1964-），男，本科，副主任药师，主要从事药品检验工作，Email：mzssxk@yahoo．com．cn。
