高效液相色谱法测定药用辅料苯甲醇中苯甲酸和苯甲醛含量

目的建立HPLC法同时测定药用辅料苯甲醇中苯甲酸和苯甲醛的含量。方法采用Acclaim 120 C18柱(4.6 mm×250 mm,5μm),流动相为乙腈-0.02%甲酸(用氨水调至p H=4.5)(30:70),流速为1.0 m L·min-1,检测波长为230 nm,柱温为35℃,进样量为20μL。结果苯甲酸在0.500 6¹5.02μg·m L-1内与峰面积线性关系良好,平均回收率均>100%,RSD均<1.3%(n=3);苯甲醛在0.505 215.02μg·m L-1内与峰面积线性关系良好,平均回收率均>100%,RSD均<1.3%(n=3);苯甲醛在0.505 2¹5.16μg·m L-1内与峰面积的线性关系良好,平均回收率均>108%,RSD均<0.15%(n=3)。结论本方法准确度高、重现性好,可用于苯甲醇中苯甲酸和苯甲醛的含量测定。

Determination of benzoic acid and benzaldehyde in pharmaceutical excipients benzyl alcohol by HPLC

Objective To establish an HPLC method for the determination of benzoic acid and benzaldehyde in pharmaceutical excipients benzyl alcohol. Methods The column was Acclaim 120 C18（4.6 mm×250 mm, 5 μm）, the mobile phase was composed of acetotrile and 0.02% formic acid（adjusted p H to 4.5 with aqua ammonia）（30 ：70）, the flow rate was 1.0 m L·min- 1, the detection wavelength was 230 nm, the temperature was 35 ℃ and the injection volume was 20 μL. Results There was a good linearity of benzoic acid and benzaldehyde at 0.500 6- 15.02 μg·mL^-1 and 0.505 2- 15.16 μg·mL^-1. The average recoveries were more than 100%（RSD 〈1.3%, n = 3） and 108%（RSD 〈0.15%, n = 3）. Conclusion This method is reproducible and accurate to determine the content of benzoic acid and benzaldehyde in benzyl alcohol.