HPLC测定肾上腺色腙注射液的含量及有关物质

Determination of Carbazochrome and related substances in Carbazochrome injection by HPLC

目的测定肾上腺色腙注射液的含量及有关物质。方法采用HPLC法,用Zorbax C18色谱柱(250 mm×4.6 mm,5μm);甲醇-0.01 mol.L-1磷酸二氢钾溶液(含0.1%三乙胺,磷酸调pH3.8)(25:75)为流动相;流速1.0 ml.min-1;检测波长355 nm;柱温30℃;进样量10μl。结果在该色谱条件下,肾上腺色腙与其相邻杂质峰能完全分离,在10~100μg.ml-1线性关系良好(r2=0.9999)。结论所建方法简便、准确、专属性好,可作为肾上腺色腙注射液中主药的测定及有关物质检查。

OBJECTIVE To establish a method for the determination of Carbazochrome and its related substances in Carbazochrome injection.METHODS The HPLC system consisted of a Zorbax C18 column(250 mm× 4.6 mm,5 μm),a mixture of methanol and solution of potassium phosphate(25:75) as mobile phase,the flow rate was 1.0 ml·min-1and the detection wavelength was at 355 nm.The column temperature was 30℃.RESULTS Carbazochrome could be completely separated from other impurities.The linear range of carbazochrome was 10-100 μg·ml...