氯氮平片有关物质的测定

Detection of related substances in clozapine tablets

建立UPLC法测定氯氮平片的有关物质。十八烷基硅烷键合硅胶为填充剂,以水-三氟乙酸(体积比,1000∶1)为流动相A,以乙腈-三氟乙酸(体积比,1000∶1)为流动相B,梯度洗脱,检测波长为257nm,柱温为40℃,流速为0.5mL/min,进样量为2μL。氯氮平线性回归方程为y=15409.06x+109.54,相关系数R=0.9999,杂质D线性回归方程为y=4949.45x+36.91,相关系数R=0.9999;定量限:氯氮平为0.021μg/mL,杂质D为0.063μg/mL,回收率分别为102.7%、101.4%、100.4%,RSD分别为0.6%、0.5%、0.5%。该方法准确可靠,可用于氯氮平片有关物质的测定。

To establish a method for the detection of related substances in clozapine tablets by UPLC.The HPLC method was used in C18 column,water-trifluoroacetic acid(1000∶1)as mobile phase A,acetonitrile-trifluoroacetic acid(1000∶1)as mobile phase B,gradient elution detection,the wavelength was 257 nm,the column temperature was 40℃,flow was 0.5mL/min,injection volume was 2μL.The linear equation of clozapine was y=15409.06x+109.54,R=0.9999,the linear equation of Impurity D was y=4949.45x+36.91,R=0.9999.The LOQ of clozapine was 0.021μg/mL,the LOQ of Impurity D was 0.063μg/mL.The average recovery rates of clozapine were 102.7%,101.4%and 100.4%,with RSD were 0.6%,0.5%and 0.5%.The method is acurate and reliable,and can be used to determine related substances in clozapine tablets.