目的:建立测定利培酮口服液中主药含量的方法.方法:采用高效液相色谱法.色谱柱为Hypersil BDS-C18柱,流动相为乙腈-0.5％醋酸铵溶液(用三乙胺调pH值至7.0,22∶78,V/V),流速为1.5 ml/min,检测波长为275nm,柱温为40℃,进样量为10 μl.结果:利培酮检测质量浓度在0.16～0.24 mg/ml范围内与峰面积积分值呈良好的线性关系(r=0.999 6);精密度、稳定性、重复性试验的RSD均≤0.7％；平均回收率为99.5％,RSD=0.6％ (n=9).结论:该法专属性强、灵敏度高、简便易行、结果准确,适用于利培酮口服液中主药的含量测定.%OBJECTIVE:To establish a method for the content determination of main component in Risperidone oral solution.METHODS:HPLC method was adopted.The separation was performed on Hypersil BDS-C18 column with mobile phase consisted of acetonitrile-0.5％ ammoninm acetate (pH adjusted to 7.0 with triethylamine,22∶78,V/V) at the flow rate of 1.5 ml/min.The detection wavelength was set at 275 nm and column temperature was 40 ℃.The sample size was 10 μl.RESULTS:The linear range of risperidone was 0.16-0.24 mg/ml (r=0.999 6) with an average recovery of 99.5％ (RSD=0.6％,n=9).RSDs of precisions,stability and reproducibility tests were lower than and equal to 0.7％.CONCLUSIONS:The method is specific,sensitive,simple and accurate,and it can be used for the content determination of main components in Risperidone oral solution.
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