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本文报道了0.5%催醒宁注射液的高效液相色谱定量测定法,该法应用ZROBAX ODS 柱,以甲醇:0.1mol/L 醋酸钠溶液(5:3)为流动相,检测波长254nm, 其推测水解产物、氧化产物及加速条件分解产物对测定无干扰,催醒宁在0.02～0.1mg/ml 呈良好线性,相关系数0.99958,回收率99.01±0.80%(n=10)。应用此法测定了本品在不同温度,不同加热时间的剩余浓度。实验证明,催醒宁含量与加热时间的变化规律符合一级动力学方程,由 Arrhenius 方程推算0.5%催醒宁注射液25℃t0.9为21.4年,证明该注射液稳定性良好。
In this paper, a method for the quantitative determination of 0.5% Xuxinning injection by HPLC was developed. The method was applied on a ZROBAX ODS column with a mobile phase of methanol: 0.1mol / L sodium acetate solution (5: 3) It was speculated that hydrolyzate, oxidized product and accelerated decomposition products had no interference on the determination. The correlation coefficient was 0.99958 and the recovery rate was 99.01 ± 0.80% (n = 10). This method was applied to determine the product at different temperatures, different heating time of the remaining concentration. Experiments show that the content of reminding Ning and heating time changes in line with the first-order kinetics equation, calculated by the Arrhenius equation reminder Ning injection at 25 ℃ t0.9 21.4 years, proves that the stability of the injection is good.