HPLC测定马来酸法舒地尔注射液中马来酸法舒地尔含量和有关物质

 目的采用高效液相色谱法建立马来酸法舒地尔含量测定及其有关物质检查的方法。方法Centurysil-C₁₈BDS柱(4.6 mm×200 mm,5μm),以0.08 mol·L^-1磷酸二氢钠缓冲液-乙腈-三乙胺-磷酸(89∶11∶2.5∶0.6)(pH为7.0)为流动相,检测波长为272 nm。结果制剂中辅料对主药测定无干扰,法舒地尔与有关物质完全分离。在10.0～60.0 mg·L^-1内峰面积与质量浓度呈良好的线性关系。精密度(RSD=0.28%)良好。平均回收率为100.2%。结论本方法简便,迅速,准确,专属性强。

Determination of Fasudil Maleate and Its Related Substance in Fasudil Male ate Injection by HPLC

OBJECTIVE To establish a HPLC method for determining the content and related substance of fasudil maleate in fasudil maleate injection.METHODS A centurysil-C₁₈ BDS column(4.6 mm×200 mm,5 μm) was used,and the mobile phase consisted of 0.08 mol·L sodium dihydrogen phosphate buffer-acetonitril-triethylamine-phosphoric acid(89∶11∶2.5∶0.6)(pH was 7.0).The determination wavlength was 272 nm.RESULTS The excipients did not interfere with the determination of fasudil.Using this method,fasudil and its related substance were absolutely separated.The linear range of the fasudil was 10.0～60.0 mg·L^-1.The precision of the method(RSD=0.28%) was good.The average recovery was 100.2%.CONCLUSION The method is simple,efficient,accurate,and specific.