Dissolution and in vitro-in vivo correlations of propiverine hydrochloride sustained-release capsules

An HPLC-UV method was developed to determine the concentration of propiverine hydrochloride in the dissolution medium.The analyte was chromatographically separated on a Shimadzu Shim-pack VP-ODS C₁₈ column (150 mm×4.6 mm,5 μm) using a mixture of methonal-phosphate buffer (0.05 mol/L) (70∶30) as mobile phase.An appropriate method was established for the dissolution testing.The small beaker method of dissolution testing in Chinese Pharmacopoeia was chosen.250 mL distilled water was used as the dissolution medium at 50 r/min and (37±0.5) ℃.Weibull model was selected as the description of propiverine hydrochloride sustained release capsule’s releasing mechanism.In vitro-in vivo correlation evaluation was studied by Loo-Riegelman method,which proved that in vitro-in vivo correlation was significant.