梯度洗脱高效液相色谱法检测注射用辅酶A有关物质

目的建立注射用辅酶A有关物质的测定法。方法采用Hypersil ODS色谱柱,以磷酸盐缓冲液(pH7.0)与乙腈为流动相梯度洗脱;检测波长259 nm,柱温25℃,流速1.0 mL/min。结果在此条件下,辅酶A与有关物质得到有效分离,辅酶A、5′-磷酸腺苷、氧化型辅酶A和3′-脱磷辅酶A的检测限分别为0.01 u,0.15 ng,50 ng和100 ng。结论此法专属、灵敏、准确,适用于药品的质量控制。

Determination of related substances in Coenzyme A for injection by gradient elution

Purpose To establish a HPLC method for determining the related substances in Coenzyme A for injection.Methods Chromatography column:HypersilODS,mobile phase:acetonitrile-phosphates buffer(pH 7.0),detection wavelength:259 nm,column temperature:25 ℃,Flow rate:1 mL/min.Results A satisfactory separation condition among Coenzyme A and the related impurities was obtained,the lowest limit for detection was 0.01 u for coenzyme A,0.15 ng for Adenosine 5′-monophosphate,50 ng for coenzyme A oxidized and 100 ng for 3′-Dephosphocoenzyme A.Conclusion The method was proved to be suitable for controlling the quality,which has the advantages of selectivity,sensitivity and accuracy.