HPLC测定盐酸丙卡特罗片中有关物质的含量  

Determination of Related Compounds in Procaterol Hydrochloride Tablets by HPLC

作　　者：冯文 傅萍 刘峰 田洁 FENG Wen;FU Ping;LIU Feng;TIAN Jie(Sichuan Institute for Drug Control/NMPA Key Laboratory for Technical Research on Drug Products in Vitro and in Vivo Correlation,Chengdu 611731,China;Center for Drug Evaluation,NMPA,Beijing 100000,China)

机构地区：[1]四川省药品检验研究院/国家药品监督管理局药物制剂体内外相关性技术研究重点实验室,成都611731 [2]国家药品监督管理局药品审评中心,北京100000

出　　处：《中国现代应用药学》2021年第18期2239-2244,共6页Chinese Journal of Modern Applied Pharmacy

摘　　要：目的建立高效液相色谱法测定盐酸丙卡特罗片中的有关物质。方法采用Waters Symmetry ShieldTM C18(4.6 mm×150 mm,5μm),以1.0 mmol·L^(-1)庚烷磺酸钠-甲醇-醋酸(81∶15∶4)为流动相;流速为1.0 mL·min^(–1);柱温为35℃;检测波长为254 nm。结果杂质A、B、C线性相关系数均>0.999,其平均回收率为95.0%~105.0%(n=9),校正因子分别为1.0,0.4,0.5。结论该法专属性强、简便可靠,适用于盐酸丙卡特罗片有关物质检查,为其质量控制提供检测依据。OBJECTIVE To establish an HPLC method for the determination of related compounds in procaterol hydrochloride tablets.METHODS The determination method was developed on a Waters Symmetry Shield;C;column(4.6 mm×150 mm,5μm),with 1.0 mmol·L^(-1)sodium heptanesulfonate-methanol-acetic acid(81∶15∶4) as mobile phase at a flow rate of 1.0 mL·min^(-1).The column temperature was maintained at 35℃and the UV detection wavelength was set at 254 nm.RESULTS The correlation coefficient of impurity A,B and C was all more than 0.999 and the average recovery rates were95.0%–105.0%(n=9).And the correction factors of impurity A,B,C were 1.0,0.4,0.5,respectively.CONCLUSION The method was specific,simple and reproducible for the determination of related compounds in procaterol hydrochloride tablets and provide reliable detection basis for its quality control.

关 键 词：盐酸丙卡特罗片 有关物质 高效液相色谱法 

分 类 号：R917.101[医药卫生—药物分析学]