重酒石酸去甲肾上腺素注射液含量测定方法优化研究与方法学验证  

Study on Optimization of Determination Method of Norepinephrine Tartrate Injection and Methodological Validation

作　　者：王小婷 黎芷明 陈昊旻 周小琴 黄子健 张铭儒 王秋芸 WANG Xiaoting;LI Zhiming;CHEN Haomin;ZHOU Xiaoqin;HUANG Zijian;ZHANG Mingru;WANG Qiuyun(Guangzhou Baiyunshan Mingxing Pharmaceutical Company Limited,Guangdong Guangzhou 510250,China)

机构地区：[1]广州白云山明兴制药有限公司,广东广州510250

出　　处：《广州化工》2024年第21期124-127,共4页GuangZhou Chemical Industry

摘　　要：对《中国药典》2020版第二部重酒石酸去甲肾上腺素注射液含量测定方法进行优化并进行方法学验证。采用Thermo scientific Hypersil GOLD (250 cm×4.5 mm,5μm)色谱柱;检测波长为280 nm,进样体积10μL,流速1.0 mL/min。研究结果表明该方法能准确测定重酒石酸去甲肾上腺素注射液的含量,线性范围为0.08~0.24 mg/mL;R^(2)=0.999 9;平均回收率为99.89%,RSD=0.4%;重复性RSD=0.2%;精密度RSD=0.3%;重酒石酸去甲肾上腺素对照品溶液在冰箱(2~8℃)条件下放置7 d稳定。此方法专属性强、准确度高,可保证重酒石酸去甲肾上腺素注射液的质量。The content determination method of norepinephrine bitartrate injection in Chinese Pharmacopoeia(2020 Edition,Part II) was optimized and methodological verification was carried out.Thermo scientific Hypersil GOLD(250 cm×4.5 mm,5 μm) column was used,the detection wavelength was 280 nm,the injection volume was 10 μL,and the flow rate was 1.0 mL/min.The results showed that the method could accurately determine the content of norepinephrine bitartrate injection,and the linear range was 0.08 to 0.24 mg/mL,R~2 was 0.999 9,the average recovery rate was 99.89%,RSD was 0.4%,repeatability RSD was 0.2%,precision RSD was 0.3%.The metoclopramide hydrochloride reference solution was stable for 7 d when stored in a refrigerator(from 2 to 8 ℃).This method has strong specificity and high accuracy,and can ensure the quality of norepinephrine bitartrate injection.

关 键 词：重酒石酸去甲肾上腺素注射液 含量测定 液相色谱法 

分 类 号：R917[医药卫生—药物分析学]