RP-HPLC法测定贝诺酯及其有关物质

DETERMINATION OF BENORILATE AND ITS IMPURITIES BY RP-HPLC

摘要: 目的:为分离并检查贝诺酯及其制剂中的多种微量有机杂质并测定贝诺酯含量。方法:在ODS柱上,以甲醇—水(56∶44 ,pH3-5) 为流动相,UV240 nm 检测。结果:贝诺酯与对乙酰氨基酚、乙酰扑热息痛、阿司匹林、水杨酸和萨罗酚等5 种有关物质均可完全分离,检查了国产贝诺酯及其制剂中的有关物质并测定了贝诺酯的含量。结论:本法可对以上杂质进行检查并测定贝诺酯的含量。

Abstract: AIM: To investigate the related substances and determine the contents of benorilate with a new RP HPLC method. METHODS: An ODS column was used. The mobile phase consists of methanol and water (56∶44, pH adjusted to 3.5 with phosphoric acid). The UV detector was set at 240 nm. RESULTS: Benorilate and its related substances paracetamol, acetyl paracetamol, aspirin, salicylic acid and salophen can be separated. The impurities from benorilate products and its preparations were tested and the contents of benorilate were determined. CONCLUSION: The new method can be used to detect the related substances and determine the contents of benorilate.