| 陈岩蓓,蒋文玉.RP-HPLC测定琥珀酸美托洛尔缓释片的含量及有关物质[J].安徽医药,2015,19(12):2306-2309. |
| 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 |
| 投稿时间：2015-09-14 |
| DOI： |
| 中文关键词: 琥珀酸美托洛尔 HPLC法 含量 有关物质 |
| 英文关键词: metoprolol succinate sustained-release tablet HPLC content related substance 〖XC20150164-2.TIF %90%90〗2 破坏图谱 |
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| 中文摘要: |
| 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,5 μm),以乙酸铵缓冲液(3.9 g的乙酸铵溶解于810 mL的水中,加入10.0 mL的冰乙酸,2.0 mL的三乙胺,3.0 mL的磷酸)—乙腈=82 ∶18,流速1.0 mL·min-1,检测波长275 nm,进样量10 μL。 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。 |
| 英文摘要: |
| 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 mL water, with an addition of 10.0 mL acetic acid, 2.0 mL triethylamine, 3.0 mL phosphoric acid)- acetonitrile=82 ∶18. The flow rate was 1.0 mL·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. |
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