HPLC法测定小儿咳喘灵口服液中山梨酸钾的含量

Determination of Potassium Sorbate in Xiao'er Kechuanling Oral Solution by HPLC

目的:建立HPLC法测定小儿咳喘灵口服液中防腐剂山梨酸钾的含量。方法:采用Phenomenex Gemini C18(250 mm×4.6 mm,5μm)色谱柱,以0.02 mol·L^(-1)磷酸二氢钠溶液(用磷酸调p H至4.0)-乙腈(80∶20)为流动相,流速为1.0 ml·min^(-1),检测波长为262 nm,柱温为30℃,进样体积为20μl。结果:山梨酸钾浓度在8.584~85.840μg·ml^(-1)范围内与峰面积呈良好线性关系(r=0.999 9),平均回收率为100.0%,RSD为0.47%(n=9),山梨酸钾检测限为0.43 ng,定量限为1.29 ng。结论:经过方法学验证,本法可用于小儿咳喘灵口服液中防腐剂山梨酸钾的含量测定。

Objective： To develop a method for the determination of potassium sorbate in Xiao＇er Kechuanling oral solution by HPLC. Methods： A Phenomenex Gemini C18 column （250 mm ×4.6mm,5μm） was used, and the mobile phase was 0.02 mol L -1 sodium dihydrogen phosphate（ adjusting pH to 4.0 with phosphoric acid）-acetonitrile （80： 20）. The flow rate was 1.0 ml min -1 and the detection wavelength was set at 262 nm. The column temperature was 30% and the injection volume was 20μl. Results： The linear range of potassium sorbate was 8. 584-85. 840 μg ml-1 （ r =0.999 9） ： The recovery of potassium sorbate was 100.0% and the RSD was 0.47% （n = 9）. The limit of detection was 0.43 ng and the limit of quantitation was 1.29 ng. Conclusion： After the valida- tion, the method can be used for the assay of potassium sorbate in Xiao＇er Keehuanling oral solution.