摘要
目的建立复方非洛地平控释片2组分释放度测定方法。方法 以0.3%十二烷基硫酸钠(SDS)水溶液(磷酸调pH2.5)-乙腈-甲醇体积比(40∶50∶10)为流动相,流速1 mL.min-1,柱温25℃,进样量20μL,采用Agilent Eclipse C18(4.6 mm×250 mm,5μm)色谱柱于233 nm处进行复方非洛地平控释片中非洛地平(FEL)和酒石酸美托洛尔(MET)释放度的检测。结果 非洛地平和酒石酸美托洛尔的相对保留时间分别为6.20和8.45 min,分离度达8.58,线性范围分别为1～24、10～240μg.mL-1,平均回收率分别为99.99%和99.91%,重复性及中间精密度实验2种药物的相对标准偏差(RSD)均小于2%。结论本方法快速、灵敏、准确,可用于复方非洛地平控释片释放度的测定。
OBJECTIVE To establish an HPLC method to determine the dissolutions of felodipine and metoprolol tartrate in compound felodipine controlled release tablets. METHODS An HPLC method was established with Agilent Eclipse C18 column （4. 6 mm × 250 mm,5 μm） . A mixture of 0. 3% SDS （pH adjusted to 2. 5 with phosphoric acid） -acetonitrile-methanol V： V： V（40： 50： 10） was used as the mobile phase. The column temperature was 25 ℃. The flow rate was 1 mL . min ^-1 and the detection wavelength was set at 233 nm. RESULTS The relative retention time of felodipine and metoprolol tartrate was 6. 20 and 8.45 min respectively. The linear ranges of these two drugs were 1 -24 μg . mL^-1 （ r =0. 999 9） and 10 -240 μg . mL^-1 （ r =0. 999 9）. The average recoveries of felodipine and metoprolol tartrate were 99. 99% and 99.91% respectively. The RSDs of this method were all less than 2%. CONCLUSION The established method is sensitive, accurate and reliable for determination of the dissolutions of felodipine and metoprolol tartrate in compound felodipine controlled release tablets.
出处
《中国药学杂志》
CAS
CSCD
北大核心
2013年第12期1015-1018,共4页
Chinese Pharmaceutical Journal
基金
国家"重大新药创制"科技重大专项资助项目(2012ZX09301003-001-009)
