柱前衍生化HPLC法测定N(2)-L-丙氨酰-L-谷氨酰胺注射液的含量  

Determination of N(2)-L-alanyl-L-glutamine in N(2)-L-alanyl-L-glutamine injection by HPLC with pre-column derivatization

作　　者：张云楚[1] 王丹丹[2] 

机构地区：[1]江苏省药品检验所,江苏南京210008 [2]中国药科大学,江苏南京210009

出　　处：《中国生化药物杂志》2006年第6期364-366,共3页Chinese Journal of Biochemical Pharmaceutics

摘　　要：目的建立柱前衍生化高效液相色谱（HPLC）法测定N（2）-L-丙氨酰-L-谷氨酰胺注射液含量的方法。方法 采用异硫氰酸苯酯作柱前衍生剂，色谱柱为Waters sunfire ODS柱（4．6mm×250mm），流动相为：乙腈-0．1mol／L醋酸钠（用稀醋酸调整pH5．50）为44：56，柱温30％，检测波长254nm.结果线性范围为0.025～2.5mg／mL（r=0．9998），平均加样回收率为99．9％，RSD为0．5％。结论此法操作简单快速，灵敏度高，结果准确可靠．适用于N（2）-L-丙氨酰-L-谷氨酰胺注射液中N（2）-L-丙氨酰-L-谷氨酰胺的含量测定。Purpose To establish a method using HPLC with pre-column derivatization for assay of N（2）- L-alanyl-L-glutamine injection. Methods The derivative solution was PITC. The column was waters sunfire ODS（4.6 mm×250 mm）. The mobile phase was composed of acetonitrile-0.1 mol/L sodium acetate solution （pH 5.50）. The detective wavelength was 254 nm. The column temperature was 30℃. Results The linear range was 0.025-2.5 mg/mL（ r = 0.999 8） ,and the average recovery was 99.9%, RSD was 0.5% . Conclusion This method does not need the special amino acid analyzer, and is efficient, sensitive, accurate and suitable for the determination of N （2）- L-alanyl- L-glutamine injection.

关 键 词：高效液相色谱 异硫氰酸苯酯 N(2)-L-丙氨酰-L-谷氨酰胺 

分 类 号：R927.2[医药卫生—药学]