HPLC法测定盐酸美法仑中异构体的含量

Determination of the isomer in melphalan hydrochloride by HPLC

目的:建立盐酸美法仑原料药中异构体含量测定的高效液相法。方法:色谱柱为DAICEL CROWNPAK CR-I(150mm×3.0mm,5μm),流动相为pH2.0的高氯酸水溶液-乙腈(80∶20),流速为0.4m L·min^(-1),检测波长为262nm,柱温为30℃,进样量为20μL。结果:异构体在0.1377~4.59μg·m L-1范围内线性关系良好,线性回归方程为Y=122.99X-0.9045(r=0.9999);平均回收率为101.0%(n=9),RSD为2.7%。结论:建立的方法准确可靠,可用于盐酸美法仑中异构体的含量测定。

Objective： To establish an HPLC method for the determination of isomer in melphalan hydrochloride. Methods： The column was DAICEL CROWNPAK CR-I （150mm×3.0mm,5μm）.The mobile phase was consisted of perchloric acid aqueous solution （pH2.0） and acetonitrile （80：20） with a flow rate of 0.4mL·min-1 and a detection wavelength at 262nm. The column temperature was 30℃ and the injection volume was 20μL. Results： The linear range of the isomer was 0.1377-4.59 μg· mL-1. The linear regression equation was Y= 122.99X-0.9045 （r=0.9999）. The total recovery was 101.0%（n=9,RSD=2.7%）. Conclusion： The established method is accurate and could be used to determine the isomer in melphalan hydrochloride.