Sahasrabuddhey B, Nautiyal R, Acharya H, Khyade S, Luthra P K, Deshpande P B
Analytical Development Laboratory, BioArc Research Solutions, Alembic Limited, Vadodara 390003, Gujrat, India.
J Pharm Biomed Anal. 2007 Mar 12;43(4):1587-93. doi: 10.1016/j.jpba.2006.11.030. Epub 2007 Jan 4.
Three impurities in ropinirole hydrochloride drug substance at levels approximately 0.06-0.15% were detected by reverse-phase high performance liquid chromatography (HPLC). These impurities were isolated from the drug substance. These impurities were analyzed using reverse-phase HPLC. Based on the spectral data (IR, NMR and MS), structures of these impurities were characterized as 4-[2-(propylamino) ethyl]-1,3-dihydro-2H-indol-2-one hydrochloride (impurity-A), 5-[2-(diropylamino) ethyl]-1,4-dihydro-3H-benzoxazin-3-one hydrochloride (impurity-B) and 4-[2-(diropylamino) ethyl]-1H-indol-2,3-dione hydrochloride (impurity-C). Synthesis of these impurities is discussed.
通过反相高效液相色谱法（HPLC）检测到盐酸罗匹尼罗原料药中存在三种杂质，含量约为0.06 - 0.15%。这些杂质从原料药中分离出来。使用反相HPLC对这些杂质进行分析。根据光谱数据（红外光谱、核磁共振光谱和质谱），这些杂质的结构被鉴定为4-[2-(丙基氨基)乙基]-1,3-二氢-2H-吲哚-2-酮盐酸盐（杂质A）、5-[2-(二丙基氨基)乙基]-1,4-二氢-3H-苯并恶嗪-3-酮盐酸盐（杂质B）和4-[2-(二丙基氨基)乙基]-1H-吲哚-2,3-二酮盐酸盐（杂质C）。文中还讨论了这些杂质的合成方法。
