RP-HPLC法测定盐酸沙格雷酯片剂的含量

RP-HPLC determination of sarpogrelate hydrochloride tablets

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.