【摘要】 目的 建立高效液相色谱法筛查分析儿童口服液体制剂中抑菌剂苯甲酸钠和山梨酸钾。方法 采用Ecosil C₁₈（250 mm×4.6 mm,5μm）色谱柱，以0.02 mol·L^-1乙酸铵溶液-乙腈（95∶5）为流动相，检测波长为225 nm，流速为1.0 mL·min^-1。结果 苯甲酸钠和山梨酸钾分别在1.082～108.2μg·mL^-1（r=1.000 0）和1.140～114.0μg·mL^-1（r=1.000 0）范围内与峰面积呈良好的线性关系；检测限分别为0.220 9和0.202 1 ng，定量限分别为0.736 4 ng和0.673 8 ng；平均回收率分别为100.4%和100.7%,RSD分别为0.4%（n=9）和0.5%（n=9）；分析15个品种共21批样品，检出的苯甲酸钠和山梨酸钾均在参考限度范围。结论 本实验建立的分析方法专属性强、灵敏度高、适用性好，可用于不同类型儿童口服液体制剂的质量控制。更多还原

【Abstract】 Objective To establish an HPLC method for screening analysis of sodium benzoate and potassium sorbate in pediatric oral liquid preparations. Methods The chromatography was performed on Ecosil C₁₈ column（250 mm×4.6mm, 5μm） using. 0.02 mL·min^-1 ammonium acetate solution-acetonitrile（95∶5, V/V） as mobile phase at a flow rate of 1.0mL·min^-1, and detected at 225 nm. Results Sodium benzoate and potassium sorbate showed a good linear relationship with the peak area in the range of 1.140～114.0 μg·mL^-1（r=1.000 0）and 1.082～108.2 μg·mL^-1（r=1.000 0）, respectively.The limit of quantification（LOD） were 0.220 9 ng and 0.202 1 ng, and the limit of quantification（LOQ） were 0.673 8 and 0.736 4 ng. The average recoveries were 100.4% with an RSD of 0.4%（n=9） and 100.7% with an RSD of 0.5%（n=9）.In 21samples of 15 species, the sodium benzoate and potassium sorbate detected were within the reference limits. Conclusion The proposed HPLC method is specificity, accuracy and serviceability. It can be successfully applied in quality control of different types of pediatric oral liquid preparations.更多还原