摘要
目的:建立高效液相测定盐酸沙格雷酯片中盐酸沙格雷酯含量的方法。方法:采用 Agilent ZORBAX Eclipse C_(18)柱(150him×4.6 mm,5 μm);流动相:甲醇-0.05 mol·L^(-1)磷酸二氢钾缓冲液(磷酸调 pH 为3.0)(65:35);柱温:25 ℃;流速:1.0 mL·min^(-1);检测波长218 nm。结果:盐酸沙格雷酯浓度在5.6~224.0~g·mL^(-1)范围内线性关系良好(r=0.9999,n=5);精密度试验 RSD 为0.79%(n=9);低、中、高浓度平均加样回收率分别为99.4%,99.4%,100.3%(n=3),RSD 为0.23%,0.11%,0.41%。结论:本文所建立的盐酸沙格雷酯含量测定方法可行。
Objective : To establish an RP - HPLC method for the content determining in sarpogrelate hydrochloride of sarpogrelate hydrochloride tablets. Methods:The separation was peformed with Agilent ZORBAX Eclipse C18 col- umn( 150 mm× 4. 6mm,5μm) , and the mobile phase was methanol - 0.05 mol · L^- 1 potassium dihydrogen phos- phate buffer(65: 35, adjusted pH to 3.0 with phosphoric acid), the flow rate was 1.0 mL· min^- 1 and the detected wavelength was 218 nm, the column temperature was 25 ℃. Results:The contents assay was established for sarpogrelate hydrochloride with a good linear relation in the range of 5.6 - 224.0μg ·mL^- 1 ( r = 0. 9999, n = 5 ) , the precision of method RSD was 0.79% (n = 9 ), the low, medium and high recovery was 99.4%, 99.4%, 100.3 % (n = 3) ,RSD was 0.23%, 0. 11%, 0.41%. Conclution: The method is applicable for determination of sarpogrelate hydrochloride.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2008年第2期282-283,共2页
Chinese Journal of Pharmaceutical Analysis
基金
温州市社会科研项目(Y20070112)