【摘要】 目的 :建立反相高效液相色谱法测定奥扎格雷有关物质。方法 :采用DiamonsilC18(15 0mm× 4 .6mm ,5 μm)色谱柱 ,以磷酸盐缓冲液 乙腈 (92∶8)为流动相 ,紫外检测波长为 2 74nm ,流速为 1.0mL·min-1。结果 :高效液相色谱法检测定奥扎格雷有关物质 ,降解产物和主峰达到有效分离。 3批自制样品的测定符合规定。结论 :该方法适用于测定奥扎格雷原料药中有关物质的测定 ,方法简便 ,结果准确 ,专属性强更多还原

【Abstract】 OBJECTIVE A RP HPLC method was established to determine related substance in ozagrel.METHODS The analysis was conducted with a Dimonsil C 18 ( 150 mm × 4.6 mm , 5 μm ) column at room temperature,the mobile phase was consisted of phosphate buffer acetenitrile(92∶8),the detecting wavelength was 274 nm ,the flow was 1.0 mL ·min -1 .RESULTS Ozagrel was separated with its related substance thoroughly.Three batches of samples were analysed.CONCLUSION The method is proved to be accurate and reliable could be used for the anslysis of the related substance in ozagral.更多还原