HPLC法测定洛索洛芬钠缓释片中主药的含量

Determination of the content of Loxoprofen solium in Loxoprofen solium Sustained-release Tablets by HPLC

目的建立以高效液相色谱法测定洛索洛芬钠缓释片中主药含量的方法。方法色谱柱：KromasilC18,流动相为乙腈-水（38∶62,10%的磷酸溶液调节pH至3.5）,检测波长为222 nm,流速为1 ml/min,柱温为30℃,进样量是10μl。结果洛索洛芬钠检测的线性范围为9.3320-186.64μg/ml（r=0.9997）,平均回收率为100.1%,RSD=0.5%。结论本方法简便、准确、专属性强,可用于该制剂的质量控制。

Objective To establish a method for the determination of loxoprofen solium in loxoprofen solium sustained-release tablets. Methods HPLC was performed on a C18 column using acetonitrile-water （38 ： 62, pH =3.5, adjusted by 10% H3PO4 solution） as the mobile phase at a flow rate of 1 ml/min. The detection wavelength was at 222 nm. The column temperature was 30℃ and the sample size was 10 μl. Results The linear range of clarithromycin was 9. 3320 - 186. 64 μg/ml （ r = 0. 999 7 ）, the average recovery was 100. 1% （ RSD =0. 5% ）. Conclusion The method is simple, accurate, special and can be used for the quality control of loxoprofen solium sustained-release tablets.