复方谷氨酰胺肠溶胶囊中L-谷氨酰胺释放度的测定

Determination of drug release of glutamine in its enteric coated capsules

关键词:  L-谷氨酰胺  高效液相色谱  释放度

Key words:  L-glutamine  HPLC  drug release

摘要:

［目的］采用HPLC法测定复方谷氨酰胺肠溶胶囊中L-谷氨酰胺的释放度。［方法］采用NUCLEOSIL 5 NH₂ 1OOA（250 mm×4.6 mm）色谱柱，乙腈-0.05 mol·L^-1 磷酸二氢钾缓冲液（pH 4.0，70∶30）为流动相，流速1 mL·min^-1，检测波长215 nm。以转篮法测定其释放度。［结果］L-谷氨酰胺在0.5~4 μg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；日内精密度高中低3个浓度RSD分别为1.72％、0.62％、0.97％；加样回收率分别为98.0％（RSD=2.13％，n=5），99.0％（RSD=1.60％，n=5）。［结论］该方法简便准确，重现性好，结果准确，可以用于该制剂释放度的测定。

Abstract:

［Objective］To establish HPLC method for the determination of drug release of L-Glutamine in its enteric-coated capsules.［Methods］Used NUCLEOSIL 5 NH2 100A column (250 mm 4.6 mm),acetonitrile-0.05 mol L^-1 potassium di-hydrogen phosphate buffer(pH 4.0,70:30)as mobile phase at a flow rate of 1mL min^-1,the detection wave-length was 215 nm.Drug release was determined by rotating basket method.［Results］The calibration curves were linear in the range of 0.5～4 μg(r=0.9999).The within-day precision of three thickness was 1.72%,0.62%,0.97%;The average recoveries rates were 98.0%(RSD=2.13%,n=5),99.0%(RSD=1.60%,n=5).［Conclusion］This method is simple, accurate and reproducible.So this method can be used in the determination of drug release of L-glutamine in its enteric-coated Capsules.