HPLC法测定泮托拉唑钠肠溶片中泮托拉唑的含量及有关物质  

Determination of pantoprazole sodium enteric-coated tablets and related substances by HPLC method

作　　者：余诺君 郑艾妮 徐彤彤 郭日铄 李宁 YU Nuojun;ZHENG Aini;XU Tongtong;GUO Rishuo;LI Ning(School of Pharmacy,Guangdong Pharmaceutical University,Guangzhou 510006,China)

机构地区：[1]广东药科大学药学院,广东广州510006

出　　处：《广东药科大学学报》2018年第2期154-158,共5页Journal of Guangdong Pharmaceutical University

基　　金：国家自然科学基金项目(81173525)

摘　　要：目的建立高效液相色谱法测定泮托拉唑钠肠溶片中泮托拉唑的质量分数及有关物质A、B、C。方法采用Phenomenex Luna C18柱(4.6 mm×250 mm,5μm),以缓冲盐溶液(四丁基硫酸氢铵1.1 g与乙酸铵3.85 g溶解于1 000 m L水)-甲醇(体积比42.5∶57.5)为流动相;检测波长为290 nm;流速为0.7 m L/min;柱温为30℃;进样量20μL。泮托拉唑峰与有关物质A、B、C峰的分离度良好。结果泮托拉唑在80.4~321.6μg/m L范围内与峰面积线性关系良好(R=0.999 7,n=6),检测限为0.6 ng/m L,平均回收率为101.5%(RSD=0.6%,n=9)。有关物质A、B、C分别在0.006~1.604、0.014~0.882、0.003~0.600μg/m L范围内与峰面积线性关系良好,检测限分别为2.0、4.5、1.0 ng/m L,回收率分别为101.0%(RSD=1.5%,n=9)、98.4%(RSD=1.2%,n=9)、100.1%(RSD=0.9%,n=9)。结论建立的高效液相色谱法检测泮托拉唑及有关物质准确、重复性好。本方法不需要调节流动相pH,步骤简便且对色谱柱起到一定的保护作用。Objective To develop a simple method for the determination of pantoprazole and its related substances in pantoprazole sodium enteric-coated tablets.Methods Chromatography analysis was performed on Phenomenex Luna C 18(4.6 mm×250 mm,5μm)column with the mobile phase of ammonium buffer(ammonium acetate 3.85 g and tetrabutylammonium hydrogen sulfate 1.1 g in 1 000mL water):methanol(volume ratio is 42.5∶57.5).The detection wavelength was 290 nm,and the flow rate was 0.7 mL/min.The column temperature was performed at 30℃,and the injection volume was 20μL.Results Good resolution was achieved between pantoprazole and its related substances.The assay exhibits a linear dynamic range of 80.4-321.6μg/mL for pantoprazole with good correlation coefficient(R=0.999 7,n=6).The mean recovery was 101.5%(RSD=0.6%,n=9),and the limit of detection was 0.06 ng/mL.The calibration curves for related substances A,B,C were linear in the ranges of 0.006-1.604μg/mL,0.014-0.882μg/mL,and 0.003-0.600μg/mL,respectively.Their mean recoveries were 101.0%,98.4%and 101.1%.The limits of detection were 2.0,4.5,and 1.0 ng/mL,respectively.Conclusion This developed method was validated and optimized for the determination of pantoprazole and its related substances,giving significant benefits for extending the life of chromatographic columns without adjusting pH value of the mobile phase.

关 键 词：泮托拉唑钠肠溶片 高效液相色谱法 泮托拉唑 有关物质 

分 类 号：R927.2[医药卫生—药学]