消旋山莨菪碱高效液相色谱分析

Analysis of (±) Anisodamine by Means of HPLC

目前临床上应用的莨菪碱类药物绝大部分是人工合成品——消旋山莨菪碱(654-2),其分子结构为四个光学异构体即二对差向异构体(6R,2'R和6S,2'S;6S,2'R和6R,2'S),其药理作用和临床疗效与天然品相同;但消旋山莨菪碱极易混入边链脱水的副产物——阿托酸6β-羟基-3α-托品酯。作者采用高效液相色谱法对消旋山莨菪碱(Ⅰ)及副产物(Ⅱ)的纯品进行研究,选择最佳分离条件,考察多批消旋山莨菪碱的质量,并用此法进行定量分析研究。

A study on the quantitative determination of a synthetic new drug—(±) anisodamine with HPLC is described.The analysis was completed on a stainless steel column (φ4× 250mm)pack-ed with a chemical bonded phase (YWG-C18H37), the mobile phase being a mixture of methanol, water and triethylamine (V/V/V 255:45 : 0.01) with a flow rate of 1ml/min at room temperature. The (±) anisodamine was de-teced by UV at 254nm. This method is rapid, reproducible and accurate, and can be used for quantitative determination of (± ) anisodamine in dif-ferent product batches.