【摘要】：目的:改進(jìn)測(cè)定洛索洛芬鈉片中主成分含量及有關(guān)物質(zhì)的方法。方法:采用反相高效液相色譜法。色譜柱為迪馬Inspire C_(18),流動(dòng)相為乙腈-0.01 mol/L磷酸二氫鉀溶液(含0.2%三乙胺,磷酸調(diào)節(jié)p H至3.0±0.1)(62∶38,V/V),流速為1.0 mL/min,柱溫為40℃,檢測(cè)波長(zhǎng)為221 nm,進(jìn)樣量為20μL。結(jié)果:洛索洛芬鈉峰與相鄰雜質(zhì)峰達(dá)到良好分離(分離度1.5);洛索洛芬鈉檢測(cè)質(zhì)量濃度線性范圍為30.0~90.0μg/mL(r=0.999 8);洛索洛芬鈉檢測(cè)限為0.3μg/mL;精密度、穩(wěn)定性、重復(fù)性試驗(yàn)的RSD1.0%;回收率為99.00%~99.87%,RSD=0.33%(n=9)。結(jié)論:該方法準(zhǔn)確、簡(jiǎn)便、快速,適用于洛索洛芬鈉片的質(zhì)量控制。
[Abstract]:Objective: to improve the method for the determination of principal components and related substances in losuprofen sodium tablets. Methods: RP-HPLC was used. The chromatographic column was Dumas Inspire C18, the mobile phase was acetonitrile-0.01 mol/L potassium dihydrogen phosphate solution (containing 0.2% triethylamine, phosphoric acid adjusted pH to 3.0 鹵0.1) (62: 38 V / V), the flow rate was 1.0 mL/min, column temperature was 40 鈩，

本文編號(hào)：2267375