高效液相色谱法测定盐酸普萘洛尔中同分异构体杂质β-普萘洛尔的含量  

Determination of isomeric impurityβ-propranolol content in propranolol hydrochloride by HPLC

作　　者：崔萍 商少华 曹庆丰 CUI Ping;SHANG Shao-hua;CAO Qing-feng(Drug Control and Packaging Material Compatibility Research Center of Jiangsu Institute of Materia Medica Co.,Ltd.,Jiangsu Institute of Materia Medica,Nanjing 211816)

机构地区：[1]江苏省药物研究所药品检测及包材相容性研究中心,江苏省药物研究所有限公司,南京211816

出　　处：《中南药学》2024年第9期2415-2419,共5页Central South Pharmacy

摘　　要：目的建立HPLC法测定盐酸普萘洛尔中同分异构体杂质β-普萘洛尔的含量。方法采用YMC-Pack ODS-AQ(150 mm×4.6 mm,3μm)色谱柱,以十二烷基硫酸钠和磷酸二氢四丁基铵溶液-乙腈(70∶30)为流动相A,以十二烷基硫酸钠和磷酸二氢四丁基铵溶液-乙腈(30∶70)为流动相B,在线等度洗脱A-B(70∶30),流速为0.8 mL·min^(-1),检测波长为225 nm,进样体积为20μL。结果β-普萘洛尔检测限为0.1 ng,定量限为0.3 ng;β-普萘洛尔在0.015~1.981μg·mL^(-1)内呈良好的线性关系(r=0.9999);低、中、高水平的平均回收率分别为99.06%、100.4%、100.5%,RSD分别为0.18%、0.10%、0.060%(n=3)。结论本法简便、灵敏、准确、可靠,可为盐酸普萘洛尔原料药中β-普萘洛尔的质量控制提供参考。Objective To determine the content of isomeric impurityβ-propranolol in propranolol hydrochloride by HPLC.Methods YMC-Pack ODS-AQ(150 mm×4.6 mm,3μm)chromatographic column was used.Mobile phase A was lauryl sodium sulfate and four butyl ammonium dihydrogen phosphate solution-acetonitrile(70∶30),while mobile phase B was lauryl sodium sulfate and four butyl ammonium dihydrogen phosphate solution-acetonitrile(30∶70).The online isocratic elution A-B(70∶30)was used,the flow rate was 0.8 mL·min^(-1),the detection wavelength was 225 nm,and the injection volume was 20μL.Results The limit of detection ofβ-propranolol was 0.1 ng and the limit of quantification was 0.3 ng;β-propranolol showed good linearity within 0.015~1.981μg·mL^(-1)(r=0.9999);the average recovery at low,medium,and high concentration levels was 99.06%,100.4%,and 100.5%,while the RSD was 0.18%,0.10%,and 0.060%(n=3).Conclusion This method is simple,sensitive,acurate and reliable,which provides reference for the quality control ofβ-propranolol in propranolol hydrochloride.

关 键 词：盐酸普萘洛尔 同分异构体杂质 β-普萘洛尔 HPLC法 

分 类 号：R927[医药卫生—药学]