柳氮磺吡啶肠溶片耐酸力和溶出度检测方法的建立与研究

Establishment and research of detection methods for acid tolerance and dissolution rate in sulfasalazine enteric-coated tablet

目的建立柳氮磺吡啶肠溶片耐酸力和溶出度检测方法。方法溶出度试验采用篮法,依次以0.1 mol/L HCl和p H 7.5磷酸盐缓冲液作为溶出介质,转速100 r/min。高效液相色谱法对耐酸力和溶出度进行检测,采用Intersil ODS-3 C18（250 mm×4.6 mm,5μm）色谱柱,以水-异丙醇-乙腈-冰醋酸（22：11：7：0.4）为流动相,柱温40℃,流速为1.0 ml/min,检测波长为254 nm。结果柳氮磺吡啶浓度在25-300μg/ml范围内线性良好（r=0.9999）;平均回收率（n=9）为100.1%,RSD为0.4%,溶液在24 h内稳定,滤膜对主药没有吸附。结论该耐酸力和溶出度检测方法准确、重现性好、操作简单,能够有效控制产品的内在质量。

Objective To establish detection methods for acid tolerance and dissolution rate in sulfasalazine enteric-coated tablet.Methods Basket method was applied in detection of dissolution rate, with 0.1 mol/L HCl and pH 7.5 phosphate buffer solution as dissolution media, and revolving speed by 100 r/min. High performance liquid chromatography was used in detection of acid tolerance and dissolution rate. Intersil ODS-3 C18 （250 mm×4.6 mm, 5μm） was chromatographic column, and water-isopropanol-acetonitrile-glacial acetic acid （22∶11∶7∶0.4） was mobile phase, with column temperature as 40℃, flow velocity as 1.0 ml/ min, and detection wave length as 254 nm.Results Sulfasalazine had good linear in 25-300μg/ml （r=0.9999）, with the average recovery rate （n=9） as 100.1% andRSD was 0.4%. The solution was stable within 24 h, and basic remedy was not absorbed by filter membrane.Conclusion This is an accurate detection method for acid tolerance and dissolution rate, with good reproducibility and simple operation. It can effectively control inherent quality of product.