HPLC法测定比沙可啶肠溶片的含量及含量均匀度

摘要

OBJECTIVE:To establish a method for the determination of content and content uniformity in Bisacodyl enter-ic-coated tablet. METHODS:HPLC method was performed on the column of Agilent ZORBAX C18 with mobile phase of acetoni-trile-20 mmol/L ammonium acetate(adjusted pH to 5.0 with acetic acid)(55∶45,V/V),the detection wavelength was 265 nm,col-umn temperature was 30℃,flow rate was 1.0 ml/min,and the volume injection was 20 µl. RESULTS:The linear range of bisaco-dyl was 50-1 000 µg/ml(r=0.999 9);RSDs of precision,stability and reproducibility tests were lower than 1%;recovery was 99.50%-101.17%(RSD=0.5%,n=9). CONCLUSIONS:The method is reproducible with high accuracy,and suitable for the quali-ty control of Bisacodyl enteric-coated tablet.%目的：建立测定比沙可啶肠溶片含量及含量均匀度的方法。方法：采用高效液相色谱法。色谱柱为Agilent ZORBAX C18，流动相为乙腈-20 mmol/L乙酸铵溶液（冰醋酸调pH至5.0）（55∶45，V/V），检测波长为265 nm，柱温为30℃，流速为1.0 ml/min，进样量为20µl。结果：比沙可啶检测质量浓度线性范围为50～1000μg/ml（r＝0.9999）；精密度、稳定性、重复性试验的RSD＜1％；回收率为99.50％～101.17％，RSD＝0.5％（n＝9）。结论：该方法重复性好、准确度高，适用于比沙可啶肠溶片的质量控制。