HPLC测定盐酸阿扑吗啡舌下片的有关物质

Determination of related substances of Apomorphine hydrochloride sublingual tablet by HPLC

目的采用HPLC测定盐酸阿扑吗啡舌下片的有关物质。方法采用Dimasil C18柱（250 mm×4.6 mm,5μm）;乙腈-0.04 mol.L^-1磷酸二氢钾溶液（磷酸调pH3）（2：8）为流动相;检测波长272 nm。结果盐酸阿扑吗啡进样量0.8～12.4μg与峰面积的线性关系良好（r=0.9999）;最低检测限为0.8 ng。结论所建方法准确、简便、快速,适用于盐酸阿扑吗啡舌下片的质量控制。

OBJECTIVE To determine related substances of apomorphine hydrochloride sublingual tablet by RP-HPLC.METHODS The separation was performed on a Dimasil C18 column（250 mm×4.6 mm,5 μm）with acetonitrile-0.04 mol·L^-1 solution potassium dihydrogen phosphate（adjust pH to 3.0 by phosphoric acid）（2：8）as mobile phase and detection wavelength at 272 nm.RESULTS The calibration curves showed good linearity over the range of 0.4-10.0 μg（r=0.9999） and the LOD was 0.8 ng.CONCLUSION The method is simple,rapid,accurate and suitable for testing related substances of apomorphine hydrochloride sublingual tablets.