HPLC法测定氨酪酸注射液中的有关物质

目的建立测定氨酪酸注射液中有关物质检查的HPLC方法。方法采用CAPCELL PAK C18色谱柱,流动相:0.5%的三乙胺溶液(用磷酸调pH 5.5);流速:0.5 mL/min;检测波长:205 nm。结果各降解产物均可与氨酪酸主峰良好分离,方法的精密度和重复性良好(RSD<0.3%)。结论该方法准确、简便、快速,适用于氨酪酸注射液的质量控制。

Determination of related substances in aminobutyric acid injection by HPLC

Purpose To establish a HPLC method for the determination of aminobutyric acid and its related substances.Methods A CAPCELL PAK C18 column(250 mm×4.6 mm,5 μm)with UV detection at 205 nm,and 0.5% triethylamine solution as the mobile phase(adjusted to pH 5.5 with phosphoric acid) were used.The flow rate was 0.5 mL/min,and the temperature of the column was 35℃.Results An excellent separation was achieved for aminobutyric acid and its related substances;The reproducibility and precision of the method were good(RSD<0.3%).Conclusion This method was accurate,simple,quick and effective for testing related substances in aminobutyric acid.It was also suitable for the quality control for aminobutyric acid