高效液相色谱法测定马来酸阿塞那平的有关物质

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,5μm）,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0.45~1458μg·ml^-1浓度范围内线性关系良好（r=1.0000）,各杂质在0.4~30.0μg·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。

Determination of Related Substances in Asenapine Maleate by HPLC

Objective：To develop a quantitative HPLC method for the analysis of eight impurities in active pharmaceutical ingredi-ent （API） asenapine maleate. Methods：The substances were analyzed using an Inertsil ODS-3 C18 column （250 mm × 4. 6 mm, 5μm）, 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 separa-ted completely from the impurities. The calibration curve of asenapine was linear within the range of 0. 45-1 458 μg · ml^-1 （ r =1. 000 0）, and that the impurities was linear within the range of 0. 4-30. 0μg·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.