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目的:建立高效液相色谱法测定环磷腺苷葡萄糖注射液的含量及有关物质。方法:色谱柱为phenomenex C18柱,流动相为0.05 mol/L磷酸二氢钾溶液(内含0.01 mol/L四丁基溴化铵):乙腈(体积比为85:15);检测波长为259 nm;流速为1.0 ml/min;进样量为20μl。结果:环磷腺苷在99.48-232.12μg/ml范围内,峰面积与浓度呈良好的线形关系,平均回收率为99.33%,RSD=0.51%,n=9;最低检测限约为0.08ng/ml。结论:HPLC法测定环磷腺苷葡萄糖注射液的含量及有关物质,结果显示峰形对称,重现性好,并具有操作简便、快速、准确等优点,可用于该药的质量控制。
Objective: To establish a method for the determination of cyclic adenosine monophosphate glucose injection and its related substances by high performance liquid chromatography. METHODS: The mobile phase consisted of 0.05 mol / L potassium dihydrogen phosphate solution (containing 0.01 mol / L tetrabutylammonium bromide): acetonitrile (85:15 by volume) at a detection wavelength of 259 nm; flow rate 1.0 ml / min; injection volume 20μl. Results: The linear range of peak area and concentration of cyclic adenosine monophosphate was 99.48-232.12μg / ml, the average recovery was 99.33%, RSD was 0.51%, n = 9. The minimum detection limit was about 0.08ng / ml. Conclusion: HPLC method for the determination of cyclic adenosine monophosphate glucose injection and related substances, the results showed peak shape symmetry, reproducibility, and has the advantages of simple, rapid and accurate, and can be used for the quality control of the drug.