【摘要】 目的:建立反相高效液相色谱法定量测定马来酸阿塞那平中的8个杂质。方法:色谱柱采用Inertsil ODS-3 C18(250 mm×4.6 mm,5 μm),流动相A为0.1%三氟乙酸水溶液,流动相B为乙腈,以1.0 ml·min-1的流速进行梯度洗脱,检测波长为220 nm,柱温为35℃。结果:阿塞那平与各杂质峰良好分离,阿塞那平在0.45~1458 μg·ml-1浓度范围内线性关系良好(r=1.0000),各杂质在0.4~30.0 μg·ml-1浓度范围内线性关系良好(r>0.999);平均回收率93.1%~106.7%(n=9)。结论:本方法操作简便、灵敏度高、重复性好、专属性和耐用性较强,可用于测定马来酸阿塞那平原料药的有关物质。更多还原

【Abstract】 Objective: To develop a quantitative HPLC method for the analysis of eight impurities in active pharmaceutical ingredient( API) asenapine maleate. Methods: The substances were analyzed using an Inertsil ODS-3 C18 column( 250 mm × 4. 6 mm,5 μm),and gradiently eluted by the mobile phase A of 0. 1% aqueous trifluoroacetic acid and mobile phase B of acetonitrile in a flow rate of 1. 0 ml·min- 1 with the detection wavelength of 220 nm and the column temperature of 35℃. Results: Asenapine was separated completely from the impurities. The calibration curve of asenapine was linear within the range of 0. 45-1458 μg · ml- 1( r =1. 0000),and that the impurities was linear within the range of 0. 4-30. 0 μg·ml- 1( r >0.999). The mean recovery of the impurities was 93. 1%-106. 7%( n = 9). Conclusion: The method is simple,sensitive and reproducible with good specificity and reliability,which can be used in the quality control of asenapine maleate.更多还原