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目的建立高效液相色谱法测定比沙可啶肠溶片的体外释放度。方法采用Agilent ZORBAX SB-C_(18)色谱柱(4.6 mm×150 mm,5μm),以20 mmol·L~(-1)的乙酸铵溶液(冰醋酸调节pH 5.0)-乙腈(45∶55)为流动相,检测波长为265 nm。结果比沙可啶在1.0~15μg·m L~(-1)内线性关系良好;平均回收率为100.4%,RSD为0.8%。A企业3批样品45 min内比沙可啶肠溶片的释放度分别为83%,81%,79%;B企业3批样品45 min内比沙可啶肠溶片的释放度分别为56%,59%,61%。结论该释放度实验条件可以较客观地反映产品的内在质量,为不同厂家同一制剂质量的区分提供可靠依据。
Objective To establish a HPLC method for the determination of in vitro release of bisacodyl enteric-coated tablets. Methods A 20 mmol·L -1 ammonium acetate solution (pH 5.0 with glacial acetic acid) -acetonitrile (45:55) was used on an Agilent ZORBAX SB-C 18 column (4.6 mm × 150 mm, 5 μm) As mobile phase, the detection wavelength is 265 nm. Results Bisacodyl showed good linearity in the range of 1.0 ~ 15μg · m L -1 with an average recovery of 100.4% and a RSD of 0.8%. A three batches of samples within 45 min of the release of bisaccatine enteric-coated tablets were 83%, 81%, 79%; B batches of three batches of samples within 45 min the release of bisacodyl enteric-coated tablets were 56% 59%, 61%. Conclusion The experimental conditions of release can objectively reflect the intrinsic quality of products and provide a reliable basis for the distinction of the same preparation quality of different manufacturers.