高效液相色谱法测定盐酸法舒地尔原料药及注射液的含量

摘要

目的：采用高效液相色谱（HPLC）法测定盐酸法舒地尔原料药及注射液的含量。方法采用 Phenomenex Prodigy ODS C18（2）100A (150 mm ×4.6 mm，5μm)色谱柱，以1.0％三乙胺水溶液（用磷酸调 pH 至7.0）-甲醇（50：50）为流动相，流速为0.8 mL / min，柱温为40℃，检测波长为275 nm，进样量为20μL。结果盐酸法舒地尔质量浓度在3～60μg / mL 范围内与其峰面积呈良好线性关系，线性方程为 A ＝1.93×104 C -1.73×103，r ＝0.9999（ n ＝7）；平均回收率为99.50％，RSD 为0.87％（ n ＝9）。结论该方法简便、精密、回收率高，重现性好，可用于盐酸法舒地尔原料药及注射液的含量测定。%Objective To establish a HPLC method to determine the content of fasudil hydrochloride raw material drug and Fasudil Hy-drochloride Injection. Methods The Phenomenex Prodigy ODS C18(2) 100A column (150 × 4. 6mm,5μm) was adopted,the mobile phase was 1. 0% - triethylamine aqueous solution(adjusting to pH 7. 0 with phosphoric acid)- methanol(50 : 50),the flow rate was 0. 8 mL / min,the column temperature was 40℃ and detecting wave length was 275 nm. Results The mass concentration of fasudil hy-drochloride in the range of 3 - 60 μg / mL( r = 0. 999 9,n = 7)had good linear correlation with the area of the test peak,the linear e-quation was A = 1. 93 × 104 C - 1. 73 × 103,r = 0. 999 9( n = 7);the average recovery rate was 99. 49%( n = 9,RSD = 0. 8% ). Conclusion The method is simple and precise with high recovery rate and good reproducibility,which can be used for the determination of the con-tent of fasudil hydrochloride raw material drug and Fasudil Hydrochloride Injection.