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目的:建立测定富马酸(R,R’)-戊乙奎醚原料药及其有关物质含量的高效液相色谱法。方法:色谱柱为Ultimate XB-C18(250 mm×4.6 mm,5μm);流动相:A为甲醇,B为20 mmol·L-1KH2PO4溶液(pH5.0),采用梯度洗脱(以A相比例表示:0→10 min,55%~75%;10→50 min75%);流速1.00 mL·min-1,检测波长206 nm。结果:富马酸(R,R)-戊乙奎醚与其9个中间体达到较好的分离。结论:该方法专属性好,简捷、快速,能有效检出富马酸(R,R)-戊乙奎醚原料药中的有关物质。
Objective: To establish a HPLC method for the determination of fumaric acid (R, R ’) penehyclidine hydrochloride and its related substances. Methods: The column was Ultimate XB-C18 (250 mm × 4.6 mm, 5 μm). The mobile phase consisted of A methanol and B 20 mmol·L -1 KH 2 PO 4 solution (pH 5.0) : 0 → 10 min, 55% -75%; 10 → 50 min 75%); the flow rate was 1.00 mL · min-1 and the detection wavelength was 206 nm. Results: The better separation of fumaric acid (R, R) - penehyclidine and its nine intermediates was achieved. Conclusion: The method is specific, simple and rapid, and can effectively detect the related substances in the crude drug substance of R, R and Penehyclidine.