| 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. |
| liying,zhengzhibo,pengpeng,zhangfuli,linliya,hujiangyuan,shaojianfen.Determination of the Related Substances in Papaverine Hydrochloride API by HPLC[J].Chin J Mod Appl Pharm(中国现代应用药学),2024,41(13):36-35. |
|
| 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 |
| DOI：10.13748/j.cnki.issn1007-7693.20230961 |
| 分类号: |
| 基金项目: |
|
| Determination of the Related Substances in Papaverine Hydrochloride API by HPLC |
|
liying1, zhengzhibo2, pengpeng2, zhangfuli3, linliya3, hujiangyuan4, shaojianfen4
|
|
1.School of Pharmacy, Fudan University;2.Collaborative Innovation Center of Yangtze River Delta Region Green Pharmaceuticals, Zhejiang University of Technology;3.State Pharmaceutical Administration of Shanghai Institute of Pharmaceutical Industry;4.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. |
| Key words: papaverine hydrochloride HPLC related substance |
