摘要
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 an HPLC method for the determination of the release rate of bisacodyl enteric-coated tablets. METHODS Agilent ZORBAX SB-C（18） column（4.6 mm×150 mm, 5 μm） was used with the mobile phase of 20 mmol·L^-1 ammonium acetate（acetic acid adjust pH 5.0）-acetonitrile（45∶55）, at the detection wavelength of 265 nm. RESULTS The calibration curve of bisacodyl was linear in the range of 1.0-15 μg·m L^-1. The average recovery was 100.4%, with RSD of 0.8%. The bisacodyl release rate at 45 min of three batches of A samples were 83%, 81% and 79%; the bisacodyl release rate at 45 min of three batches of B samples were 56%, 59% and 61%. CONCLUSION The inherent quality of the product can be objectively reflected in the above conditions. Furthermore, it has a significant distinction of the same agents from different sources.
作者
孙婷
姜建国
郭永辉
SUN Ting JIANG Jianguo GUO Yonghui(Hebei Institute for Drug Control, Shijiazhuang 050011, China)
出处
《中国现代应用药学》
CAS
CSCD
2017年第1期81-84,共4页
Chinese Journal of Modern Applied Pharmacy
