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
李颖 1郑志波 2彭朋 2张福利 3林丽娅 3胡江渊 4邵坚芬4
作者信息
- 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
- 折叠
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NanoChrom ChromCore 120 C8色谱柱,以磷酸二氢钾溶液(3.4g·L-1磷酸二氢钾水溶液,磷酸调pH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 mL·min-1,检测波长238nm,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.
Abstract
OBJECTIVE To establish an HPLC method for determination of the related substances in papaverine hydrochloride.METHODS NanoChrom ChromCore 120 C8 column was used;the mobile phase A consisted of 3.4 g·L-1 potassium dihydrogen phosphate aqueous solution,adjust pH t0 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Key words
papaverine hydrochloride/HPLC/related substance引用本文复制引用
出版年
2024
NETL
NSTL
万方数据