罗红霉素缓释胶囊含量和释放度测定方法研究

摘要

Objective:To establish a method for determining content and releasing rate of roxithromycin sustained release cap-sules.Methods: The HPLC method was performed on C18 column with a mobile phase of 0.067 mol· L -1 ammonium dihydro-gen phosphate (0.3% TEA adjust pH to 7.5)-acetonitrile (60∶40) and detecting wavelength was set at 210 nm.The releasing rate test was performed with phosphate buffer ( pH 6.8 ) as dissolution media and sample was collected at 2 ,4 and 8 h.Results:The calibration curve was linear in the range of 0.22-2.00 mg· ml -1 ( R2 =0.9999 ).The average recovery was 101.50% with RSD of 1.07%.The accumulated release rate of 2,4 and 8h were 15%-45%,40%-70%and above 70%respectively.Con-clusion: The method is simple and accurate and can be used for the determination of content and releasing rate of roxithromycin sustained release capsules.%目的：建立罗红霉素缓释胶囊含量和释放度测定方法。方法：采用高效液相色谱法，色谱柱为ZORBAX SB-C18（4.6 mm ×150 mm，5μm），0.067 mol· L-1磷酸二氢铵溶液（三乙胺含量0.3％，调pH值至7.5）-乙腈（60∶40）为流动相，检测波长210 nm，用外标法计算罗红霉素缓释胶囊含量；释放度测定以磷酸盐缓冲液（pH 6.8）为溶剂，溶出2，4，8 h时取样测定。结果：含量测定在0.22～2.00 mg· mL-1（ R2＝0.9999）浓度范围内呈良好的线性关系，平均回收率为101.50％（ RSD＝1.07％）；样品在2，4，8 h的释放率分别相应为标示量的15％～45％、40％～70％和70％以上。结论：该方法简便、准确，适用于罗红霉素缓释胶囊含量和释放度的测定。