异硫氰酸苯酯柱前衍生法测定门冬氨酸鸟氨酸注射液含量

Determination of ornithine-aspartate injection by RP-HPLC with precolumn phenylisothio cyanate derivatization

目的:建立一种用异硫氰酸苯酯柱前衍生的高效液相色谱方法测定门冬氨酸鸟氨酸注射液的含量。方法:选用 Dia-monsil(TM)钻石 C_(18)(250 mm×4.6 mm,5 μm)色谱柱,流动相 A 为0.1 moL·L^(-1)醋酸钠缓冲液(pH 6.5)-乙腈(93:7);流动相 B 为乙腈-水(80:20),进行梯度洗脱。检测波长为254 nm。结果:门冬氨酸鸟氨酸溶液在101.06～303.18μg·mL^(-1)浓度范围内,峰面积与浓度呈良好的线性关系(r=0.9990),回收率为99.1%(RSD=0.60%)。结论:本方法重复性好,定量准确,可用于门冬氨酸鸟氨酸注射液的含量测定。

Objective ： RP - HPLC with phenylisothio cyanate precolumn derivation was developed the content of ornithine- aspartate injection. Method：The HPLC method was conducted on a Diamonsil（TM） C18 column （250 mm × 4. 6 mm,5 μm）, mobile phase A consisting of 0. 1 moL · L ^- 1 sodium acetate buffer （ pH 6.5 ） - acetonitrile （93： 7） ,mobile phase B consisting of acetonitrile -water（80： 20） , gradient elution was used. The detective wavelength was 254 nm. Results：The standard curve of omithine - aspartate was linear in the concentration range of 101.06 - 303 · 18 μg · mL^-1（ r = 0. 9990）, the recoveries of ornithine - aspartate were 99. 1% （RSD ： 0. 60% ）. Conclusion ： The present method is reliable and relatively simple for the determination of ornithine - aspartate injection.