复方非洛地平缓释片含量测定方法的研究

Determination of felodipine and metoprolol tartrate in compound felodipine sustained-release tablets

目的对复方非洛地平缓释片中酒石酸美托洛尔和非洛地平的含量测定方法进行研究。方法 采用反相高效液相色谱法,Spherisorb C18色谱柱(150mm×4.6mm,5μm),流动相为十二烷基硫酸钠水溶液(取十二烷基硫酸钠2.88 g,磷酸1.96 g,加水溶解并稀释到1 000 mL)-乙腈(40:60),流速1.0 mL·min-1,检测波长254 nm,进样量10μL。结果酒石酸美托洛尔和非洛地平的线性范围分别为0.4-2.0 mg·mL-1和0.04-0.2 mg·mL-1,回收率分别为99.5％和99.0％,RSD分别为1.7％和1.5％。结论该方法能够简单、快速、准确地同时测定酒石酸关托洛尔和非洛地平的含量。

OBJECTIVE: A reversed phase HPLC method was developed to determine the contents of metoprolol tartrate and felodipine in compound felodipine sustained-release tablets. METHODS: Spherisorb C18 column(150 mm × 4.6 mm, 5 μm) was used, and the mobile phase was composed of 0.02 mol&middotL-1 phosphoric containing 2.88 g&middotL-1 sodium dodecy sulfate-acetonitrile (4:6). The detection wavelength was at 254 nm with the flow rate at 1.0 mL&middotmin-1. RESULTS: The linear range was 0.4-2.0 mg&middotmL-1 for metoprolol tartrate and 0.04-0.2 mg&middotmL-1 for felodipine, respectively. The average recoveries of metoprolol tartrate and felodipine were 99.5% (RSD = 1.7%) and 99.0% (RSD = 1.5%), respectively. CONCLUSION: This method appeared to be rapid, simple and accurate.