HPLC法测定盐酸贝那替秦原料药及其注射剂的含量和有关物质  

HPLC determination of benactyzine hydrochloride and related substances in the injection

作　　者：管海燕[1] 李卓恒[1] 于彩平[1] 金竹[1] 卢来春[1] 

机构地区：[1]第三军医大学大坪医院野战外科研究所药剂科,重庆400042

出　　处：《第三军医大学学报》2013年第23期2542-2546,共5页Journal of Third Military Medical University

基　　金：国家科技重大专项课题"重大新药创制"(2011ZXJ09102-01B)~~

摘　　要：目的建立HPLC测定盐酸贝那替秦原料药及其注射剂的含量和有关物质的方法。方法以乙腈-磷酸二氢钾溶液（每1000毫升含6.80g磷酸二氢钾、0.556g庚烷磺酸钠）35：65为流动相；采用反相C。。色谱柱，以1.0mL／min流速，210nm检测波长，30℃柱温，20灿进样量为色谱条件进行测定。结果盐酸贝那替秦原料药及注射液中各杂质峰峰面积之和不超过对照溶液主峰面积的1％；盐酸贝那替秦在浓度1～200o.g／mL范围内具有良好线性关系（r=0.9995），高、中、低浓度的平均回收率分别为98.99％（RSD=0.67％）、99.96％（RSD=0.10％）、101.21％（RSD=0.11％）；日内（n=3）及日问精密度（n=5）RSD均小于2％，定量限1.7ng，检测限0.4ng。结论本实验方法专属性强、准确度高，可用于盐酸贝那替秦原料药和注射液的质量控制。Objective To develop a high performance liquid chromatography （HPLC） method for detecting benaetyzine hydrochloride and its related substances in the injection. Methods HPLC was performed to detect benactyzine and its related substances under the wave length of 210 nm under 30℃. The chromatographic conditions were as follow ： the mixed solvent of acetonitrile and buffer of potassium dihydrogen phosphate （each 1 000 mL containing 6.80 g of potassium dihydrogen phosphate, 0. 556 g sodium heptanesulfonate） （35：65） was used as mobile phase, flow rate was 1 mL/min, injection volume was 20 μL. Results The total peak areas of related substances did not exceed 1% of the main peak area of reference solution. The linear ranges of benaetyzine hydrochloride were 1 to 200 μg/mL （r = 0. 999 5 ）. The average recoveries of high, medium and low concentrations were 98.99% （RSD = 0.67% ）, 99.96% （RSD = 0.10% ）, and 101.21% （RSD =0. 11% ）respectively. The RSD of intra-day （n =3） and inter-day assay （n = 5） were less than 2%. The limit of quantitation was 1.7 ng, and the limit of detection was 0.4 ng. Conclusion Our HPLC method is proved to be highly selective, accurate and suitable for the quality control of benaetyzine hydrochloride injection.

关 键 词：盐酸贝那替秦 含量测定 有关物质 HPLC 

分 类 号：R927.2[医药卫生—药学] R944.11