| HPLC 测定盐酸罂粟碱原料药中的有关物质 |
| |
| 引用本文： | 李颖,郑志波,彭 朋,张福利,林丽娅,胡江渊,邵坚芬. HPLC 测定盐酸罂粟碱原料药中的有关物质[J]. 中国现代应用药学, 2024, 41(13): 36-35 |
| |
| 作者姓名： | 李颖 郑志波 彭 朋 张福利 林丽娅 胡江渊 邵坚芬 |
| |
| 作者单位： | 复旦大学药学院,浙江工业大学 长三角绿色制药协同创新中心,浙江工业大学 长三角绿色制药协同创新中心,上海医药工业研究院有限公司,上海医药工业研究院有限公司,浙江博崤生物制药有限公司,浙江博崤生物制药有限公司 |
| |
| 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 C8色谱柱，以磷酸二氢钾溶液（3.4g/L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92.6%~101.9%，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。
|
| 关 键 词： | 盐酸罂粟碱 高效液相色谱法 有关物质 |
| 收稿时间： | 2023-04-10 |
| 修稿时间： | 2023-06-19 |
Determination of the Related Substances in Papaverine Hydrochloride API by HPLC |
| |
| liying,zhengzhibo,pengpeng,zhangfuli,linliy,hujiangyuan and shaojianfen. Determination of the Related Substances in Papaverine Hydrochloride API by HPLC[J]. The Chinese Journal of Modern Applied Pharmacy, 2024, 41(13): 36-35 |
| |
| Authors: | liying zhengzhibo pengpeng zhangfuli linliy hujiangyuan shaojianfen |
| |
| Affiliation: | School of Pharmacy, Fudan University,Collaborative Innovation Center of Yangtze River Delta Region Green Pharmaceuticals, Zhejiang University of Technology,Collaborative Innovation Center of Yangtze River Delta Region Green Pharmaceuticals, Zhejiang University of Technology,State Pharmaceutical Administration of Shanghai Institute of Pharmaceutical Industry,State Pharmaceutical Administration of Shanghai Institute of Pharmaceutical Industry,Zhejiang Boxian Biopharmaceutical Corporation Ltd,Zhejiang Boxian Biopharmaceutical Corporation Ltd |
| |
| Abstract: | OBJECTIVE To establish an HPLC method for determination of the related substances in Papaverine Hydrochloride. METHODS ChromCore C8 column was used; the mobile phase A consisted of 3.4g/L 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 92.6%~101.9% 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. |
| |
| Keywords: | papaverine hydrochloride HPLC related substance |
|
| 点击此处可从《中国现代应用药学》浏览原始摘要信息 |
|
点击此处可从《中国现代应用药学》下载免费的PDF全文 |
|
