HPLC法测定苯巴比妥钠注射液有关物质及含量  

Determination of Content and Related Substances in Phenobarbital Sodium Injection by HPLC

作　　者：娄志红[1] 孙煌[1] 姜连阁[1] 白政忠[1] 

机构地区：[1]黑龙江省药品检验所,哈尔滨150001

出　　处：《中国药品标准》2009年第3期202-205,共4页Drug Standards of China

摘　　要：目的:建立苯巴比妥钠注射液中含量和有关物质测定的HPLC方法。方法:色谱柱为Rainbow彩虹C18(4.6 mm×250mm,5μm),流动相为pH 4.5缓冲盐(称取三水合醋酸钠6.6 g和3 mL冰醋酸,加水至1 000 mL,必要时用冰醋酸调节pH值至4.5±0.1)-甲醇(3∶2),检测波长为254 nm,按外标法以峰面积进行计算。结果:苯巴比妥钠在393～1 967 mg.L-1浓度范围内线性关系良好,r=1.000 0;平均回收率为100.2%,RSD=1.0%。专属性试验结果表明本品在热、酸、碱、氧化和光照条件下均有不同程度的降解,各降解产物峰与主成分峰均能达到较好的分离。结论:该法专属性好,简捷、快速、准确,适用于苯巴比妥钠注射液含量测定及有关物质检查。Objective： To establish an HPLC method for determination of content and related substances in Phenobarbital Sodium Injection. Method： The Rainbow C18 column （4. 6 mm ×250 mm,5 μm） was used. The mobile phase consisted of pH 4. 5 Buffer solution （ Dissolve about 6. 6 g of sodium acetate trihydrate and 3.0 mL of glacial acetic acid in 1 000 mL of water if necessary,with glacial acetic acid to the pH of 4. 5 ± 0. 1 ） - methanol （ 3 ： 2 ）. The detection wavelength was 245 nm. The content was determined by external standard. Results： There was a good linearship in the range of 393 - 1 967 mg · L^-1 （r = 1. 000 0）. The average recovery was 100. 2% ,with RSD 1.0%. Conclusion： A specific, simple, rapid, accurate and suitable method is established for determination of content and related substances in Phenobarbital Sodium Injection.

关 键 词：HPLC法 苯巴比妥钠注射液 含量 有关物质 

分 类 号：R593.1[医药卫生—内科学] R978.1[医药卫生—临床医学]