【摘要】 目的建立苦参素氯化钠注射液中苦参素的测定方法。方法采用高效液相色谱法,色谱柱:Lichrospher-C18柱(150 mm×6.0 mm),流动相:0.02 mol/L磷酸二氢钠-磷酸缓冲液(pH7.0,含0.2%三乙胺)∶甲醇(70∶30),流速为1.0 mL/min,检测波长为220 nm,苦参素含量测定采用外标法,杂质检查采用面积归一化法。结果在优化的色谱条件下,苦参素与杂质间可完全分离,苦参素浓度在26~91μg/mL内线性关系良好,含量测定平均回收率为99.48%,RSD为0.86%。结论此法专属性强,操作方便,结果准确,重现性好。更多还原

【Abstract】 OBJECTIVE To establish the method for determining kurarinone in Kurarinone Sodium Chloride Injection.METHOD HPLC method was used,with chromatographic column at Lichrospher-C₁₈（150 nm × 6.0 nm）,mobile phase at 0.02 mol/L,natrium biphosphoricum-phosphoric acid（pH 7.0,containing 0.2% triethylamine） and methanol ratio at 70∶30,flow rate at 1.0 mL/min,and detection wavelength at 220 nm.External reference method was used to determine the content of kurarinone and area normalization method was used to check on the impurities.RESULT Under optimized spectrum,kurarinone was completely separated from the impurities,with a concentration of 26～91 μg/mL and fine linear relation.The average recovery rate was 99.48% and RSD was 0.86%.CONCLUSION This method has strong specificity and is convenient and accurate with good reproducibility.更多还原