摘要
目的:建立以反相高效液相色谱法测定盐酸异丙嗪注射液中主药和有关物质含量的方法。方法:色谱柱采用DiamonsilC18,以0.05mo·lL-1磷酸二氢铵(pH3.2)-乙腈(70∶30)为流动相,流速1.0mL·min-1,检测波长249nm,检测3批盐酸异丙嗪注射液样品中主药和有关物质含量。结果:盐酸异丙嗪检测浓度线性范围为5.07～101.32μg·mL-1(r=0.9995);平均回收率为100.3%(RSD=0.33%,n=6);有关物质各杂质与主药峰之间的分离度良好。盐酸异丙嗪检测限和定量限分别为20、80ng·mL-1,3批有关物质的含量分别为1.9%、1.7%、1.0%。结论:本法操作简便,灵敏度高,结果准确,可有效控制盐酸异丙嗪注射液的质量。
OBJECTIVE： To develop the RP-HPLC method for the determination of main component and related substances in promethazine hydrochloride injection. METHODS： The determination was performed on Diamonsil C18 column using 0.05 mol·L-1 ammonium dihydrogen phosphate （pH 3.2）-acetonetrile （70 ∶ 30） as the mobile phase. The detection wavelength was set at 249 nm and flow rate was 1.0 mL·min-1 for the determination of 3 batches of promethazine hydrochloride injections. RESULTS： The linear range of promethazine hydrochloride were 5.07～101.32 μg·mL-1 （r=0.999 5） with an average recovery of 100.3% （RSD=0.33%, n=6）. Good separation of promethazine hydrochloride and its related substances could be achieved. The limit of detection and quantitation were 20 ng·mL-1 and 80 ng·mL-1. The contents of related substances were 1.9%, 1.7% and 1.0%. CONCLUSION： The method is simple, sensitive and accurate for the quality control of promethazine hydrochloride injection.
出处
《中国药房》
CAS
CSCD
北大核心
2010年第17期1608-1609,共2页
China Pharmacy
