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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 the determination of dissolution of flucloxacillin sodium tablets. Methods: High performance liquid chromatography (HPLC) was performed on a Hypersil BDS C_ (18) column (200 mm × 4.6 mm, 5 μm) with a mobile phase of 0.02 mol·L -1. Potassium dihydrogen phosphate buffer (adjusted to pH 5.0 with dilute NaOH) -acetonitrile (70:30) was used. The detection wavelength was 225 nm, the flow rate was 1.0 ml · min -1 and the column temperature was 25 ℃. According to the Chinese Pharmacopoeia 2005 edition two appendix “dissolution assay ” second method dissolution. Results: Three batches of samples were eluted 94% of the labeled amount. Conclusion: The method is simple, accurate and reliable. Dissolution test for flucloxacillin tablets.