HPLC法测定安神补脑液中防腐剂的含量

Content Determination of Antiseptics in Anshen Bunao Oral Liquid by HPLC

目的:建立测定安神补脑液中防腐剂含量的方法。方法:采用高效液相色谱法。色谱柱为Agilent Zorbax SB-C_(18),流动相为乙腈-0.05%磷酸溶液(梯度洗脱),流速为1.0 mL/min,检测波长为236 nm,柱温为30℃,进样量为10μL。结果:苯甲酸和羟苯乙酯检测质量浓度线性范围分别为12.85～128.54μg/mL(r=0.999 9)、4.05～40.48μg/mL(r=0.999 8);定量限分别为0.514、1.012μg/mL,检测限分别为0.171、0.353μg/mL;精密度、稳定性、重复性试验的RSD<1.0%;加样回收率分别为99.38%～100.21%(RSD=0.31%,n=6)、97.96%～100.72%(RSD=0.91%,n=6)。结论:该方法操作简单、结果准确,可用于安神补脑液中防腐剂的含量测定。

OBJECTIVE： To establish a method for the determination of antiseptics in Anshen bunao oral liquid. METHODS： HPLC method was adopted. The determination was performed on Agilent Zorbax SB-C18 column with mobile phase consisted of acetonitrile-0.05% phosphorice acid solution （gradient elution） at the flow rate of 1.0 mL/min. The detection wavelength was set at 236 rim, and column temperature was 30℃. The injection volume was 10 μL. RESULTS： The linear range of benzoic acid and eth- ylparaben were 12.85-128.54μg/mL（r=0.999 9） and 4.05-40.48 μg/mL（r=0.999 8）, respectively. The limits of quantitation were 0.514, 1.012 pg/mL. The limits of detection were 0.171, 0.353 μg/mL. RSDs of precision, stability and reproducibility tests were all lower than 1.0%. The recoveries were 99.38%-100.21% （RSD=0.31% ,n=6）, 97.96%-100.72% （RSD=0.91% ,n=6）. CONCLUSIONS ： The method is simple and accurate, and can be used for content determination of antiseptics in Anshen bunao oral liquid.