HPLC法测定盐酸伪麻黄碱缓释片的相关物质

Stability-indicating HPLC assay for pseudoephedrine hydrochloride sustained-release tablets

报道盐酸伪麻黄碱缓释片的相关物质HPLC测定方法。使用色谱柱DiamonsilTMC18(250mm×4.6mm,5μm),流动相0.5%三乙胺(用磷酸调pH值至3.0)甲醇(9∶1),检测波长为257nm,对盐酸伪麻黄碱缓释片的相关物质进行测定,并确定其限量。本方法能有效检查样品的相关物质。本法快捷、简便,适用于盐酸伪麻黄碱缓释片的质量控制。

The stability of the stressed samples of pseudoephedrine hydrochloride sustained-release tablets was evaluated after acid, alkali, hydrogen peroxide, heat and light treatment. Reversed-phase high-performance liquid chromatography for the simultaneous determination of impurities associated with the tablets was developed and validated. The examined samples were analyzed on a C_ 18 column (250 mm×4.6 mm, 5 μm) and a mobile phase containing 0.5% triethylamine(adjusted the pH to 3.0 with phosphoric acid)-methanol(9∶1), a flow rate of 1.2 mL/min and UV detection wavelength of 257 nm. The degradants generated during the test were well detected, suggesting that HPLC can be used for the quality control of pseudoephedrine hydrochloride sustained-release tablets.