反相高效液相色谱法测定小儿咳喘灵口服液中绿原酸的含量

Quantitative Determination of Chlorogenic Acid in Xiao'er Kechuanling Oral Liquid by RP-HPLC

目的建立高效液相色谱法测定小儿咳喘灵口服液中绿原酸含量的测定方法。方法采用RP-HPLC法,色谱柱为kromasil C18(150mm×4.6mm,5μm);流动相:乙腈-0.4%磷酸水溶液(12∶88),流速:1.0mL/min,柱温:30℃,紫外检测波长:327nm。结果绿原酸的线性范围为4.24-106μg/mL,相关系数r=0.99997;加样回收率为100.06%;检测限为0.45μg;精密度实验RSD=0.87%;重现性实验RSD=1.30%;稳定性实验RSD=0.75%;4批小儿咳喘灵口服液样品中绿原酸含量在1.259-1.301 mg/mL之间。结论该方法简便,快速,分离效果好,结果准确,适用于小儿咳喘灵口服液中绿原酸的质量控制。

Objective To develop an RP-HPLC method for the determination of chlorogenic acid in Xiao＇er Kechuanling oral liquid.Methods The method used RP-HPLC,the column was kromasil C18（150mm×4.6mm,5μm）;the mobile phase was acetonitrile-0.4%phosphoric acid solution（12∶88）,the flow rate was 1.0 mL/min,the column temperature was at 30℃,UV detection wavelength was 327 nm.Results The linearity ranges of chlorogenic acid was 4.24-106μg/mL,the correlation coefficient was 0.99 997,the average recovery of adding sample was 100.06%,the examination limits is 0.45μg,the RSD（n=5） of measurement precision test was 0.87%,the RSD（n=5） of reproducibility between tests was 1.30%,the RSD of stability was 0.75%,the content of chlorogenic acid in Xiao＇er Kechuanling oral liquid was 1.259-1.301mg/mL.Conclusion The method was simple,rapid,separation efficiency good,accurate.It is suitable for the determination of chlorogenic acid in xiao＇er kechuanling oral liquid.