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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 the related substances of apomorphine hydrochloride sublingual tablets by HPLC. Methods The mobile phase consisted of Dimasil C18 column (250 mm × 4.6 mm, 5 μm), acetonitrile-0.04 mol·L-1 potassium dihydrogen phosphate solution (adjusted to pH 3 with phosphoric acid) (2: 8) and the detection wavelength was 272 nm. Results The linear range of apomorphine hydrochloride injection was 0.8 ~ 12.4μg (r = 0.9999). The minimum detection limit was 0.8 ng. Conclusion The proposed method is accurate, simple and rapid and is suitable for the quality control of apomorphine hydrochloride sublingual tablets.