摘要
采用HPLC法测定利培酮原料药中2-氨基吡啶（具有潜在遗传毒性）的残留量。采用ODS-BP（4.6 mm×250 mm,5μm）色谱柱,流动相为甲醇∶醋酸盐=40∶60,梯度洗脱,流速为1.0 m L/min,检测波长为290 nm。利培酮及其基因毒性物质2-氨基吡啶的线性范围分别为0.08～1.5μg/m L,平均回收率分别为97.8%。本法简便、准确、可靠、适合于利培酮原料药中2-氨基吡啶（具有潜在遗传毒性）的残留量的测定。
An HPLC method for 2- aminopyridine（ potential genotoxic） quantitative determination of riseperidone was established. The analytical column was HPLC ODS- BP（4. 6 mm × 250 mm,5 μm） column. The mobile phase was composed of methanol and acetate salt（40∶60） at a flow rate of 1. 0 m L / min. The wavelength of UV detector was290 nm. The linear ranges of 2- aminopyridine was 0. 08 ～ 1. 5 μg / m L,the average recovery of riperidone was 97. 8%.This method is rapid,accurate and reliable to determine the 2- aminopyridine content of risperidone.
出处
《广州化工》
CAS
2016年第12期122-123,157,共3页
GuangZhou Chemical Industry
关键词
利培酮
HPLC法
基因毒性
残留量
risepridone
HPLC method
potential genotoxic
residue quantity
