HPLC法测定肾上腺色腙注射液含量及有关物质

HPLC determination of carbazochrome injection and its related substances

目的:建立高效液相色谱法测定肾上腺色腙注射液含量及有关物质。方法:采用Diamonsil C_(18)色谱柱(4.6 mm×150mm,5μm),甲醇-0.01 mol·L^(-1)磷酸二氢钾溶液(含0.1%三乙胺,磷酸调节pH 3.8)(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:含量测定方法在10.7～107.4μg·mL^(-1)范围内,r=0.9999,平均回收率为100.8%;检测限为0.15 ng(S/N=3)。结论:本方法简便,结果准确,适用于肾上腺色腙注射液的质量控制。

Objective：To establish an HPLC method for determination the assay of carbazochrome injection. Method：Diamonsil C18 column（4.6 mm ×150 mm,5 μm）was used at 30℃. The mobile phase was consisted of methanol -0. 01 mol · L ^-1 potassium dihydrogen phosphate solution （include 0. 1% triethylamine, adjust to pH 3.8 with phosphoric acid）（25： 75） and detected with UV 355 nm. The flow rate was 1.0 mL · min^-1 and the injected volume was 10 μL. Results ：The linear range of the method was 10.7 - 107.4 μg · mL^-1 （r=0. 9999 ） ;The average recovery （ n = 9） was 100. 8 %. The detective limit was 0. 15 ng （ S/N = 3 ）. Conclusion： The method is convenient and accurate.