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目的:建立盐酸法舒地尔的含量测定方法。方法:采用HPLC法,色谱柱为Welchrom C_(18)(250 mm×4.6 mm,5μm),流动相为1%三乙胺水溶液(用磷酸调pH至7.0)-甲醇(60∶40),流速1.0 ml·min~(-1),检测波长275 nm,柱温30℃。结果:盐酸法舒地尔在20.16～100.8μg·ml~(-1)浓度范围内线性关系良好(r=0.999 8,n=5),平均加样回收率为99.87%,RSD为0.59%(n=9)。结论:本方法操作简便,结果准确可靠,可用于该药品的质量控制。
Objective: To establish a method for the determination of fasudil hydrochloride. Methods: The HPLC method was based on Welchrom C_ (18) (250 mm × 4.6 mm, 5 μm) with a mobile phase of 1% triethylamine in water (adjusted to pH 7.0 with phosphoric acid) -methanol (60:40) 1.0 ml · min -1, detection wavelength was 275 nm, column temperature was 30 ℃. Results: Fasudil hydrochloride showed a good linearity (r = 0.999 8, n = 5) in the range of 20.16-100.8μg · ml -1 with an average recovery of 99.87% and a RSD of 0.59% n = 9). Conclusion: The method is simple, accurate and reliable, and can be used for the quality control of the drug.