高效液相色谱法测定L-谷氨酰胺及其制剂的含量

Determination of L - Glutamine in Its Preparation by HPLC

目的:采用HPLC方法测定L-谷氨酰胺及其制剂的含量。方法:采用NUCLEOSIL 5NH_2100A(250mm×4.6mm)色谱柱,乙腈-0.05mol·L^(-1) 磷酸二氢钾缓冲液(pH4.0)(70:30)为流动相,流速1mL·min^(-1),检测波长215nm。结果:在5～50μg范围内,色谱峰面积与对照品浓度呈现良好的线性关系,r=0.9999;平均回收率分别为99.79％(RSD=0.43％,n=5),99.44％(RSD=0.30％,n=5)。结论:该方法简便准确,重现性好,在本色谱条件下L-谷氨酰胺与其分解产物能够得到很好的分离,可以准确测定L-谷氨酰胺的含量,也可用于原料及制剂有关物质的限度检查。

Objective: To establish HPLC method for the determination of L - glutamine in its preparation. Method: Using NUCLEOSIL 5 NH2 100A column (250 mm ×4. 6 mm) , acetonitrile -0. 05 mol·L-1 potassium di-hydrogen phosphate buffer (pH 4) (70:30) as mobile phase at a flow rate of 1 mL·min-1, the detection wavelength was 215 nm. Results: The calibration curves were linear in the range of 5 - 50μg ( r = 0. 999 9). The average recoveries rates were 99. 79% (RSD=0. 43%, n =5), 99.44% ( RSD = 0. 30% , n =5). Conclusion: This method is simple, accurate and reproducible. Under this condition, L -glutamine' s related substance will be separated completely from L - glutamine. So this method can be used in the determination for content of the related substance.