RP-HPLC测定琥珀酸美托洛尔缓释片的含量及有关物质

RP- HPLC determination of metoprolol succinate sustained- release tablets and its related substances

目的建立琥珀酸美托洛尔缓释片含量及有关物质的RP-HPLC方法。方法以十八烷基硅烷键合硅胶作为填充剂ZORBAX SB-C18（4.6 mm×250 mm,5μm）,以乙酸铵缓冲液（3.9 g的乙酸铵溶解于810 m L的水中,加入10.0 m L的冰乙酸,2.0 m L的三乙胺,3.0 m L的磷酸）—乙腈=82∶18,流速1.0 m L·min-1,检测波长275 nm,进样量10μL。结果琥珀酸美托洛尔在20.00~120.02 mg·L-1浓度范围内线性关系良好,检测限为0.4 ng,定量限为1.2 ng,回收率为100.75%（RSD=0.67%）,测定样品含量为99.8%,有关物质均小于0.2%。结论该方法快速,简单,稳定,重现性好,可作为琥珀酸美托洛尔缓释片的含量及有关物质的检测方法。

Objective To establish an RP- HPLC method for determination of the content of metoprolol succinate sustained- release tablets and its related substances. Methods The chromatographic separation was performed on ZORBAX SB- C18（ 4. 6 mm × 250 mm,5 μm） that was made by alkyl- bonded silica gels,ammonium acetate buffer solution（ 3. 9 g acetic ammonia dissolved in 810 m L water,with an addition of 10. 0 m L acetic acid,2. 0 m L triethylamine,3. 0 m L phosphoric acid）- acetonitrile = 82 ∶ 18. The flow rate was 1. 0 m L·min- 1. The detection wavelength was 275 nm. The sample size was 10 μL. Results There is good linearity within the range of 20. 00 ~ 120. 02 mg·L- 1. The detection limit was 0. 4 ng. The limit of quantitation was 1. 2 ng. The average recovery was 100. 75%（ RSD = 0. 67%）. Determination of the sample average content was 99. 8%,and the related substance was less than 0.2%. Conclusion The method is quick,simple,stable and repeatable,which could be used to determine the content of metoprolol succinate sustained- release tablets and its related substances.