RP-HPLC法测定洛索洛芬钠片的含量及有关物质

发布时间：2018-10-12 19:44

【摘要】：目的:改进测定洛索洛芬钠片中主成分含量及有关物质的方法。方法:采用反相高效液相色谱法。色谱柱为迪马Inspire C_(18),流动相为乙腈-0.01 mol/L磷酸二氢钾溶液(含0.2%三乙胺,磷酸调节p H至3.0±0.1)(62∶38,V/V),流速为1.0 mL/min,柱温为40℃,检测波长为221 nm,进样量为20μL。结果:洛索洛芬钠峰与相邻杂质峰达到良好分离(分离度1.5);洛索洛芬钠检测质量浓度线性范围为30.0~90.0μg/mL(r=0.999 8);洛索洛芬钠检测限为0.3μg/mL;精密度、稳定性、重复性试验的RSD1.0%;回收率为99.00%~99.87%,RSD=0.33%(n=9)。结论:该方法准确、简便、快速,适用于洛索洛芬钠片的质量控制。
[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 卤0.1) (62: 38 V / V), the flow rate was 1.0 mL/min, column temperature was 40 鈩，

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