HPLC测定比沙可啶肠溶片体外释放度

Determination of the in Vitro Release of Bisacodyl Enteric-coated Tablets by HPLC

关键词:  比沙可啶肠溶片  高效液相色谱法  体外释放度

Key words:  bisacodyl enteric-coated tablet  HPLC  in vitro release

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-C₁₈色谱柱（4.6 mm×150 mm，5 μm），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1.0~15 μg·mL^-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。

Abstract:

OBJECTIVE To establish an HPLC method for the determination of the release rate of bisacodyl enteric-coated tablets. METHODS Agilent ZORBAX SB-C₁₈ 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·mL^-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.