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目的:建立注射用复合辅酶中辅酶A的含量测定方法。方法:采用高效液相色谱法测定,色谱柱:Intersil ODS-3色谱柱(150 mm×4.6 mm,5μm),流动相:甲醇-p H 6.5磷酸二氢钾溶液(10∶90),检测波长:259 nm,流速:1.0 ml·min~(-1),柱温:30℃,进样量:20μl。结果:辅酶A浓度在1.624~32.482 u·ml~(-1)范围内与峰面积线性关系良好(r=0.999 9),平均加样回收率为102.36%,RSD为1.14(n=6)。结论:该方法简便、准确、重复性好,可用于注射用复合辅酶的质量控制。
Objective: To establish a method for the determination of coenzyme A in compound coenzyme for injection. Methods: The HPLC-MS method was used. The chromatographic column was consisted of Intersil ODS-3 column (150 mm × 4.6 mm, 5 μm), mobile phase: methanol-pH 6.5 potassium dihydrogen phosphate solution : 259 nm, flow rate: 1.0 ml · min -1, column temperature: 30 ℃, injection volume: 20μl. Results: The linear range of Coenzyme A concentration was 1.624 ~ 32.482 u · ml ~ (-1) and the peak area was linear (r = 0.999 9). The average recoveries were 102.36% and RSD was 1.14 (n = 6). Conclusion: The method is simple, accurate, reproducible and can be used for quality control of coenzyme for injection.