HPLC法测定小儿肺热咳喘口服液中3种防腐剂的含量

Determination of 3 Preservatives in Xiaoer Feire Kechuan Oral Solution by HPLC

目的:建立小儿肺热咳喘口服液中3种防腐剂苯甲酸、山梨酸、糖精钠的含量测定方法。方法:采用高效液相色谱法(HPLC),色谱柱为Thermo syncronis C_(18)(250 mm×4.6 mm, 5μm),流动相为乙腈-0.2%磷酸溶液(19∶81),流速1 mL/min,柱温30℃,检测波长320 nm,进样量10μL。结果:苯甲酸、山梨酸、糖精钠在5~60μg/mL范围内与其峰面积均呈良好的线性关系(r>0.999),平均加样回收率分别为99.72%(RSD=1.57%,n=6),97.30%(RSD=1.70%,n=6),101.37%(RSD=0.99%,n=6);苯甲酸、山梨酸、糖精钠精密度试验的RSD分别为0.07%、0.21%、0.18%。结论:实验采用的HPLC法简便、准确、专属性强、重复性好,可用于液体口服制剂中苯甲酸、山梨酸、糖精钠的含量测定。

Objective To establish a method for the determination of benzoic acid, sorbic acid and saccharin sodium in Xiaoer Feire Kechuan Oral Solution.Methods The determination by high performance liquid chromatography(HPLC) was performed on Thermo syncronis C_(18)(250 mm×4.6 mm, 5 μm)with mobile phase consisted of acetonitrile-0.2% phosphoric acid(19∶81,V/V)at the flow rate of 1 mL/min;the detection wave length was set at 320 nm, and sample size was 10 μL;the column temperature was 30 ℃.Results The linear range of benzoic acid, sorbic acid and saccharin sodium were 5-60 μg/mL(r>0.999). The average recovery rate was 99.72%, 97.30% and 101.37%. and RSD were 1.57%, 1.70% and 0.99%(n=6). The RSD of precision test were 0.07%, 0.21% and 0.18%. Conclusion The HPLC method is simple, accurate, specific and repeatable which could be used for the determination of benzoic acid, sorbic acid and saccharin sodium in Xiaoer Feire Kechuan Oral Solution.