高效液相色谱法测定右旋布洛芬缓释栓的含量及有关物质

Determination of Dexibuprofen and its related substances in Dexibuprofen sustained-release suppositories by HPLC

目的:采用高效液相色谱法测定右旋布洛芬缓释栓中右旋布洛芬含量及有关物质。方法:色谱柱ODS-C_(18)柱(250mm×4.6mm,5um);以乙腈-0.02mol·L^(1-)磷酸二氢钾溶液(pH2.50)(53:47)为流动相;检测波长为264nm。结果:线性范围为4～128mg·L^(-1)(r=1.0000),平均回收率为99.9%,RSD为0.3%(n=9)。结论:方法重复性好,准确度高,适于右旋布洛芬缓释栓的质量控制。

OBJECTIVE：TO establ：sh a HPLC methnd for detenninat：on the content andifs related substances in dex：buprofen sustained-release suppos：tor：es Method： the Hypers： 10DS C18 column （250 mm×4.6mm, 5um）was used, The acetonitrile-0.02mol·L^-1 Potass：um d：hydrogen phosphate solut：on（PH2.5）（53：47）as mobile phase,the flow rate was 1.0ml·min^-1 the detect：on wavelength was 264mm. RESULT：The linear range of dex：buprofen was 4-128mg·L^-1 （r=1.0000）,The average recovery was 99.9% w：th RSD 0.3% （n=9）. conclusion The method is sensitive,rapid and accurate, it is suitable for quality control of dexibuprofen sustained-retease supposicories.