【摘要】 目的建立高效液相色谱法测定盐酸乐卡地平原料药的有关物质。方法用十八烷基硅烷键合硅胶为填充剂,流动相为0.15 mol·L^-1的高氯酸钠（用1%高氯酸调解pH值3.6）-乙腈（V∶V=49∶51）,流速为1.5 mL·min^-1,检测波长为220 nm,进样量为20μL,柱温为25℃。结果杂质1、杂质2、杂质3、杂质4、杂质5、杂质6、杂质7、杂质8、杂质9的检测限分别为2.0×10^-3、4.0×10^-2、3.0×10^-3、3.0×10^-3、5.0×10^-3、3.0×10^-3、4.0×10^-3、8.6×10^-2、2.2×10^-2 mg·L^-1;定量限分别为6.0×10^-3、1.5×10^-3、9.0×10^-3、9.0×10^-3、1.4×10^-2、2.3×10^-2、1.5×10^-2、2.9×10^-2、4.0×10^-3 mg·L^-1。杂质1-杂质9均在质量浓度0.05～1.0 mg·L^-1内线性关系良好,相关系数r≥0.998 （n=5）;杂质1-杂质9的平均回收率分别为96.1%、101.1%、101.1%、103.0%、100.9%、99.6%、96.0%、97.3%和104.9%（n=9）。结论该方法可用于盐酸乐卡地平原料药有关物质的测定。更多还原

【Abstract】 Objective To establish an HPLC method for the determination of related substances in lercanidipine hydrochloride.Methods Octadecylsilane bonded silica was used as a filler,the mobile phase was 0.15 mol·L^-1of sodium perchlorate（pH 3.6 adjusted with 1 % perchloric acid）-acetonitrile（V∶V=49∶51）,the flow rate was 1.5 mL·min^-1,the detection wavelength was 220 nm,the injection volume was 20 μL and the column temperature was 25 ℃.Results The detection limits of impurity 1,impurity 2,impurity 3,impurity 4,impurity 5,impurity 6,impurity 7,impurity 8 and impurity 9 were 2.0×10^-3,4.0×10^-3,and 3.0×10^-3,3.0×10^-3,5.0×10^-3,3.0×10^-3,4.0×10^-3,8.6×10^-3 and 2.2×10^-2 mg·L^-1,respectively;the limit of quantification were 6.0×10^-3,1.5×10^-2,9.0×10^-3,9.0×10^-3,1.4×10^-2,2.3×10^-2,1.5×10^-2,2.9×10^-2 and 4.0×10^-2 mg·L^-1,respectively.The linear relationship of impurities 1 to 9 were good in the mass concentration of 0.05-1.0 mg·L^-1,and the correlation coefficient was r≥0.998（n=5）;the average recoveries of impurities 1 to 9 were 96.1%,101.1%,101.1%,103.0%,100.9%,99.6%,96.0%,97.3% and 104.9%,respectively（n= 9）.Conclusion This method can be used for the determination of its related substances in lercanidipine hydrochloride.更多还原