摘要
目的 鉴于原含量测定方法为间接测定的滴定法 ,定量的专属性差 ,因此建立了用 HPLC法测定乙酰谷酰胺注射液含量的方法。方法 色谱柱 :Kromasil 5μ C1 8( 2 ) 2 5 0× 4.60 ( Phenomenex) ;流动相 :0 .0 2 mol· L- 1 磷酸二氢钾溶液 ,磷酸调 p H值 3 .5 ;流速 :1.0 m L· min- 1 ,检测波长 2 0 5 nm,以外标法计算含量。结果 本法专属性强、灵敏、准确 ,该方法在 1.0 0 2 4μg～ 4.5 10 8μg浓度范围内线性关系良好 ( r=0 .9999,n=6)。回收率为 10 1.5 % ,RSD=0 .7%。 结论 建立的定量方法专属性强 。
OBJECTIVE To assay aceglutamide in aceglutamide injection by HPLC for quality control.METHODS The analytical column was Kromasil 5μ C 18(2) 250×4.60(Phenomenex).The mobile phase was potassium dihydrogen phosphate(0.02mol·L -1) ,using phosphoric acid to adjust pH 3.5 at rate of 1.0ml·min -1 And UV detector wavelength was 205nm.RESULTS A good linearity was shown in the range of 1.0024μg～4.5108μg(r=0.9999,n=6).The aveage recovery was 101.5%,and RSD was 0.7%.CONCLUSION It was established an accurate,simple,rapid qualitative method with good reproducibility to assay Aceglutamide Injection,in its content by HPLC for quality control
出处
《海峡药学》
2004年第6期43-45,共3页
Strait Pharmaceutical Journal
