HPLC测定盐酸罂粟碱原料药中的有关物质  

Determination of the Related Substances in Papaverine Hydrochloride Active Pharmaceutical Ingredients by HPLC

作　　者：李颖 郑志波 彭朋[2] 张福利[3] 林丽娅 胡江渊 邵坚芬 LI Ying;ZHENG Zhibo;PENG Peng;ZHANG Fuli;LIN Liya;HU Jiangyuan;SHAO Jianfen(School of Pharmacy,Fudan University,Shanghai 201203,China;Collaborative Innovation Center of Yangtze River Delta Region Green Pharmaceuticals,Zhejiang University of Technology,Hangzhou 310014,China;Shanghai Research Institute of Pharmaceutical Industry Co.,Ltd.,Shanghai 201213,China;Zhejiang Boxian Biopharmaceutical Co.,Ltd.,Hangzhou 311400,China)

机构地区：[1]复旦大学药学院,上海201203 [2]浙江工业大学长三角绿色制药协同创新中心,杭州310014 [3]上海医药工业研究院有限公司,上海201213 [4]浙江博崤生物制药有限公司,杭州311400

出　　处：《中国现代应用药学》2024年第13期1797-1802,共6页Chinese Journal of Modern Applied Pharmacy

摘　　要：目的 建立HPLC检测盐酸罂粟碱原料药中有关物质的方法。方法 采用Nano Chrom Chrom Core 120 C_(8)色谱柱,以磷酸二氢钾溶液(3.4 g·L^(-1)磷酸二氢钾水溶液,磷酸调p H至3.5)-乙腈(90∶10)作为流动相A,甲醇为流动相B,梯度洗脱,流速0.8 m L·min^(-1),检测波长238 nm,柱温50℃。结果 主成分与各杂质间最小分离度>1.5;主成分以及其13个杂质在各自的浓度范围内呈良好的线性关系(r>0.999);平均回收率为93.1%~101.2%,RSD为2.3%~8.1%。结论 本方法准确、灵敏、可靠,适用于盐酸罂粟碱原料药有关物质的测定。OBJECTIVE To establish an HPLC method for determination of the related substances in papaverine hydrochloride.METHODS NanoChrom ChromCore 120 C_(8) column was used;the mobile phase A consisted of 3.4 g·L^(−1) potassium dihydrogen phosphate aqueous solution,adjust pH to 3.5 with phosphoric acid-acetonitrile(90∶10),the mobile phase B was methanol,with gradient elution at the flow rate of 0.8 mL·min^(−1);the detection wavelength was 238 nm;the column temperature was 50℃.RESULTS The minimum separation between the main component and each impurity was>1.5;Papaverine and its thirteen impurities showed a good linear relationship in the self-concentration range(r>0.999);and the average recoveries were 93.1%−101.2%with RSDs of 2.3%−8.1%.CONCLUSION The method is accurate,sensitive and reliable,which is suitable for the determination of related substances in papaverine hydrochloride.

关 键 词：盐酸罂粟碱 高效液相色谱法 有关物质 

分 类 号：R917.101[医药卫生—药物分析学]