HPLC法测定盐酸法舒地尔注射液的含量  

Determination of Fasudil Hydrochloride Injection by HPLC

作　　者：宋玉才 吕永超 

机构地区：[1]鲁南制药集团股份有限公司,山东临沂276000

出　　处：《药学研究》2013年第2期90-91,共2页Journal of Pharmaceutical Research

摘　　要：目的建立高效液相色谱法测定盐酸法舒地尔注射液含量的方法。方法采用Welch Ultimate XB-C8色谱柱(4.6 mm×250 mm,5μm),流动相为0.03 mol.L-1磷酸氢二铵溶液-乙腈=76:24(用磷酸调节pH值至4.5),检测波长为275 nm,流速为1.0 mL.min-1。结果盐酸法舒地尔在90.04～210.08μg.mL-1的浓度范围内线性关系(r=0.999 9)良好,平均回收率为99.87%,RSD为0.24%。结论本方法专属强、准确度高,可用于盐酸法舒地尔注射液的质量控制。Objective To establish an HPLC method for determination of Fasudil Hydrochloride Injection. Methods A stable HPLC method was established and the chromatography was accomplished on an Welch Ultimate XB - Cs column （4.6 mm x 250 ram,5 t^m） ,the mobile phase consisted of 0.03 tool · L-1 diammonium phosphate solution - acetonitrilc = 76：24（ adjusted pH to 4.5 with phosphoric acidl ,the detection wavelength was 275 nm,the flow rate was I. 0 mL ·min i. Results The calibration curve was linear in the range of 90.04 - 210.08 g· mL -1 （ r = 0. 999 9 ） , the average recovery was 99.87% with corresponding RSD of 0.24%. Conclusion The method had strong property and high accuracy,it can be used for the quality control of Fasudil Hydrocbloride Injection.

关 键 词：高效液相色谱法 盐酸法舒地尔注射液 含量 

分 类 号：R927.2[医药卫生—药学]