RP-HPLC法测定洛索洛芬钠片的含量及有关物质

Determination of Contents and Related Substances in Loxoprofen Sodium Tablets by RP-HPLC

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RSD<1.0%;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。

OBJECTIVE： To improve the determination method for the contents of main components and related substances in Loxoprofen sodium tablets. METHODS： RP-HPLC method was adopted. The determination was performed on Inspire C18 column with mobile phase consisted of acetonitile-0.01 mol/L potassium dihydrogen phosphate （containing 0.2% triethylamine, phosphoric acid adjusted to 3.0± 0.1,62 ： 38, V/V） at the flow rate of 1.0 mL/min. The column temperature was 40℃, and the detection wave- length was set at 221 nm. The sample size was 20 μL. RESULTS： The peak of loxoprofen sodium was well separated with the peak of its related substances （R〉1.5）. The linear range of loxoprofen sodium ranged 30.0-90.0 μg/mL （r=0.999 8）. The detection lim- it of loxoprofen was 0.3 μg/mL. RSDs of precision, stability and repeatability tests were 〈1.0%. The average recovery rates ranged 99.00%-99.87% （RSD=0.33% ,n=9）. CONCLUSIONS： This method is accurate, simple, rapid and suitable for the quali- ty control of Loxoprofen sodium tablets. KEYWORDS RP-HPLC; Loxoprofen sodium tablets; Content; Related substances