HPLC检测维生素B2片中有关物质的方法优化  

Improvement of Content Determination for Related Substances in Vitamin B2 Tablets by HPLC

作　　者：房冉 王晗[1] 陈玉双 张佳茹 郑玉林 FANG Ran;WANG Han;CHEN Yushuang;ZHANG Jiaru;ZHANG Yulin(Shanghai University of Engineering Science,Shanghai 201620,China;Shanghai Maple Biological Technology Co.,Ltd.,Shanghai 201203,China)

机构地区：[1]上海工程技术大学,上海201620 [2]上海峰林生物科技有限公司,上海201203

出　　处：《中国现代应用药学》2020年第22期2764-2769,共6页Chinese Journal of Modern Applied Pharmacy

摘　　要：目的优化维生素B2片中有关物质的检测方法。方法采用Welch Ultimate AQ-C18柱(4.6 mm×250 mm,5μm),流动相为0.1%磷酸水溶液(A)-乙腈(B),进行梯度洗脱;流速为1.0 mL·min−1;检测波长267 nm;柱温30℃。结果各杂质与主成分峰分离度良好;杂质A在0.0087~0.0535μg·mL−1(r2=0.9981)、杂质B在0.0198~0.8123μg·mL−1(r2=0.9998)、杂质D在0.0073~0.8387μg·mL−1(r2=1.0000)、维生素B2在0.0113~0.4276μg·mL−1(r2=0.9994)内呈现良好的线性关系;杂质A、杂质B、杂质D平均回收率(n=9)分别为100.1%(RSD=1.6%)、100.6%(RSD=2.0%)和101.1%(RSD=1.1%)。结论本检测方法专属性强、准确度高,可用于控制维生素B2片中的有关物质。OBJECTIVE To optimize a method for related substances determination of vitamin B2 tablets.METHODS The Welch Ultimate AQ-C18 column(4.6 mm×250 mm,5μm)was used.The mobile phase A was 0.1%phosphoric acid solution and the mobile phase B was acetonitrile for gradient elution.The flow rate was 1.0 mL·min−1.The detection wavelength was 267 nm.The column temperature was 30℃.RESULTS The separation of impurity and principal component peak was good.The calibration curves were linear,the impurity A in range 0.0087−0.0535μg·mL−1(r2=0.9981),the impurity B in range 0.0198−0.8123μg·mL−1(r2=0.9998),the purity D in range 0.0073−0.8387μg·mL−1(r2=1.0000)and vitamin B20.0113−0.4276μg·mL−1(r2=0.9994).The average recoveries of impurity A,impurity B and impurity D were 100.1%(RSD=1.6%),100.6%(RSD=2.0%)and 101.1%(RSD=1.1%).CONCLUSION This detection method has strong specificity and high accuracy,and can be used to control related substances in vitamin B2 tablets.

关 键 词：维生素B2片 高效液相色谱法 有关物质 优化参数 

分 类 号：R917.101[医药卫生—药物分析学]