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

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.