法舒地尔注射液有关物质和含量测定方法研究

目的 建立法舒地尔注射液有关物质检查及含量测定方法.方法 采用高效液相色谱法,色谱柱为Xtimate C18(250 mm×4.6 mm,5μm),检测波长为275 nm,流速为1.0 mL·min-1,流动相:1％三乙胺水溶液(磷酸调pH=7.0)-甲醇(70∶30),柱温:25℃.结果 法舒地尔检测限为1.22 ng,进样量在0.121 6～0.608 0 mg·mL-1与峰面积呈良好线性关系(r=1,n=5).结论 该方法简单,结果准确可靠,可用于法舒地尔注射液的质量控制.

Content determination of related substances in fasudil injection

Objective To determine the content of related substances in fasudil injection.Methods The separation was carried out on a Xtimate C18 column(250 mm × 4.6 mm,5 μm) with the mixture of 1% triethylamine aqueous solution(adjusted to pH=7.0 with phosphoric acid) and methanol(70∶30) as the mobile phase.The column temperature was 25 ℃,the detection wavelength was 275 nm,and the flow rate was 1.0 mL·min-1.Results The detection limit for fasudil was 1.22 ng.Fasudil showed good linear relationship at 0.121 6-0.608 0 mg(r=1,n=5).Conclusion This method is simple,accurate and reliable,which can be used for the quality control of fasudil injection.