高效液相色谱法测定利培酮片含量及有关物质

Determination of content and related substances of resperidone tablets by HPLC

目的 建立高效液相色谱法测定利培酮片的含量及有关物质。方法 色谱柱为C18柱 ,流动相为醋酸铵缓冲液 (0 .1mol·L-1,pH 5 .0 ) 甲醇 乙腈 (5 0∶30∶2 0 ) ,检测波长为 2 79nm。 结果 该法专属性好 :辅料和降解产物对制剂的含量测定没有干扰 ;在 2～ 10 0 μg·mL-1浓度范围内 ,线性关系良好r =0 .9999;检测限为 0 .4ng ;平均回收率为 98.4 7% ;日内、日间RSD分别为0 .2 2 %和 0 .96 %。结论 该方法专属性强、灵敏度高、简便易行、结果准确 。

OBJECTIVE To establish an HPLC method for the determination of content and related substances of resperidone tablets. METHOD C 18 column was used. The mobile phase consisted of ammonium acetate solution (0.1mol · L -1,pH5.00)-methanol-acetonitrile (50∶30∶20) and the wavelength was set at 279nm. RESULTS This method was specific because both the excipient and related substances did not interfere the determination. There was a good linear relationship within the concentration range of 2～100μg · mL -1; the limit of detection was 0.4ng; the average recovery was 98.47%(RSD1.78%); the intra-day and inter-day RSD were 0.22% and 0.96%, respectively.CONCLUSION This method is proved to be selective, sensitive, simple and accurate for quantitative analysis of the resperidone preparation and its related substances.