反相高效液相色谱法测定富马酸喹硫平片的含量

RP-HPLC determination of quetiapine fumarate in tablets

目的 :建立富马酸喹硫平片含量测定的反相高效液相色谱法。方法 :采用HypersilODS C18(2 5 0mm×4 .6mm ,5 μm)色谱柱 ,以甲醇 0 .5 %三乙胺 (78∶2 2 ,冰醋酸调pH至 7～ 8)为流动相 ,流速 1mL·min-1,检测波长2 5 4nm ,柱温室温 ,进样量 10 μL。考察了流动相不同配比、不同 pH对富马酸喹硫平色谱行为的影响。 结果 :富马酸喹硫平与片剂辅料及其他杂质可完全分离 ;在 10～ 10 0 μg·mL-1浓度范围内线性关系良好 (r =0 .9986 ) ,平均回收率 99.7% ,RSD =1.5 %。结论 :该方法操作简便 ,结果准确 ,专属性强 。

Objective:To establish a RP HPLC method for determination of quetiapine in tablets.Methods:Instruments,reagents,and conditions adopted in the analysis were:a Hypersil ODS column(250mm×4.6mm,5μm) ,a UV detector of 254nm,a mobile phase of MeOH∶0.5% triethylamine=78∶22,its pH was adjusted with glacial HAC, a flow rate of 1.0 mL·min -1 and a column temperature of room temperature.Results:Quetiapine fumarate and tablets excipients can be completely separated with a linear range of 10～100μg·mL -1 and correlation coefficients of 0.9986.The average recovery was 99.7% with a RSD of 1.5%.Conclusion:A simple,accurate,selective,and suitable method for determination of quetiapine fumarate in tablets was established.