UPLC法测定维生素B(6)注射液的含量  

Determination the content of Vitamin B6 injection by UPLC

作　　者：高奇 郭德才 王海燕 周伟 吕宝兴 李玉琴 GAO Qi;GUO Decai;Wang Haiyan;ZHOU Wei;LV Baoxing;LI Yuqin(School of Pharmacy,Shandong First Medical University(Shandong Academy of Medical Sciences),Tai'an 271000,China;Taian Institute for Food and Drug Control,Shandong Tai'an 271016,China)

机构地区：[1]山东第一医科大学(山东省医学科学院)药学院,山东泰安271000 [2]泰安市食品药品检验检测研究院,山东泰安271016

出　　处：《中国药剂学杂志（网络版）》2023年第1期19-24,共6页Chinese Journal of Pharmaceutics：Online Edition

基　　金：山东省自然科学基金(ZR2020MH410)。

摘　　要：目的 建立快速测定维生素 B_(6)注射液含量的 UPLC 法。方法 Waters Acquity UPLC BEH C18色谱柱(2.1 mm × 100 mm, 1.7 μm),流动相 0.1%甲酸-乙腈(65 : 35),流速 0.1 mL·min^(-1),进样量 1 μL,检测波长 291 nm,室温测定。结果 维生素 B6在 0.5~50 μg·mL^(-1)的浓度范围内线性关系良好(R^(2)=0.999 2),精密度、稳定性及重复性的 RSD均 ≤ 0.01%,加样回收率为 97.4%~99.5%,LOD 及 LOQ 分别为 0.04 μg·mL^(-1)、0.12 μg·mL^(-1),该注射液中维生素 B6的含量为标示量的 94.3%。结论 该方法灵敏度高,准确度高,便于操作,可用于维生素 B6注射液的含量测定。Objective To establish a rapid UPLC method for the determination of Vitamin B6content in Vitamin B6injection. Methods Separation was achieved using a Waters ACQUITY UPLC BEH C18column (2.1 mm×100 mm, 1.7 μm) at room temperature with 0.1% formic acid and acetonitrile (65 : 35)at a flow rate of 0.1 mL·min^(-1). The injection volume was 1 μL and the detection wavelength was 291 nm.Results The linear range of Vitamin B6was 0.5~50 μg·mL^(-1)(R^(2)= 0.999 2). The RSDs of precision,stability and reproducibility were all lower than 0.01%, the recoveries were 97.4~99.5%, LOD and LOQ were 0.04 μg·mL^(-1),0.12 μg·mL^(-1,) the Vitamin B6content in the injection was 94.3% of the stated amount.Conclusion The method is sensitive, accurate and easy to operate, which can be used to test the content of Vitamin B6injection.

关 键 词：UPLC法 维生素B6注射液 含量测定 

分 类 号：R917[医药卫生—药物分析学]