摘要
目的采用反相高效液相色谱法(RP-HPLC法)测定盐酸沙格雷酯片的含量及有关物质。方法色谱柱为岛津公司Shim-pack C_(18)柱(250mm×4．6mm,5μm),以甲醇-0．05 mol/L磷酸二氢钾溶液(70：30)为流动相,流速为1．0mL/min,检测波长为272nm。结果盐酸沙格雷酯的浓度线性范围为100．6～1005．8μg/mL,r=0．999 9,最低检测限为10ng,平均回收率为99．9%,RSD为1．0%,日内和日间RSD分别为0．5%和0．7%。结论RP-HPLC法简便、快速,测定结果准确、可靠。
Objective To establish RP- HPLC method for the determination of content and the related substances of sarpogrelate hydrochloride tablets. Methods Shim- pack C18 （250 mm ×4.6 mm,5 μm） was used as the stationary phase. The mobile phase was methanol-0. 05 mol/L KH2P04 （70：30）. The flow rate was 1.0 mL/min,and the detection wavelength was 272 nm. Results The method was proved to be linear in the range of 100.6 - 1 005.8 μg/mL with a regression coefficient of 0. 999 9. The average recovery percentage of the method was 99.9% （RSD= 1.0% ）. The RSD of average contents of intra- day and inter- day was 0.5% and 0. 7% respectively. Conclusion The method is simple,rapid and the results is accurate.
出处
《中国药业》
CAS
2006年第17期32-33,共2页
China Pharmaceuticals
