高效液相色谱法测定氟氯西林钠片的溶出度

Determination the Dissolution of Flucloxacillin Sodium Tables by HPLC

目的:建立氟氯西林钠片溶出度的测定方法。方法:高效液相色谱法,色谱柱为Hypersil BDS C_(18)柱(200 mm×4.6 mm,5μm),流动相为0.02 mol·L^(-1)。磷酸二氢钾缓冲液(用稀NaOH调节pH至5.0)-乙腈(70:30),检测波长为225 nm,流速为1.0 ml·min^(-1),柱温为25℃。照中国药典2005年版二部附录"溶出度测定法"第二法测定溶出度。结果:3批样品溶出量均为标示量的94%。结论:该法简便、准确,结果可靠。可用于氟氯西林钠片的溶出度测定。

Objective： To establish a method for determination the dissolution of flucloxacillin sodium tablets. Method： HPLC method was used, for determination the Dissolution, carry out the assay as specified in ch. P. 2005 vol. Ⅱ appendix ＂Dissolution Test＂ method Ⅱ. Result： three batches sample of quantity of active ingredient dissolved were 94% of the labbled amount of flucloxacillin sodum Tablets. Conclusion： The method is simple and accurate, it can be used for determination the dissolution of flucloxacillin sodium tablets.