Development and validation of a stability-indicating HPLC method for the determination of buclizine hydrochloride in tablets and oral suspension and its application to dissolution studies

Abstract

Recebido em 10/3/11; aceito em 24/5/11; publicado na web em 22/7/11 A method using liquid chromatography has been developed and validated for determination of buclizine in pharmaceutical formulations and in release studies. Isocratic chromatography was performed on a C18 column with methanol:water (80:20 v/v, pH 2.6) as mobile phase, at a flow rate of 1.0 mL/min, and UV detection at 230 nm. The method was linear, accurate, precise, sensible and robust. The dissolution test was optimized and validated in terms of dissolution medium, apparatus agitation and rotation speed. The presented analytical and dissolution procedures can be conveniently adopted in the quality and stability control of buclizine in tablets and oral suspension.

Development and validation of a dissolution test for primaquine/polyethylene oxide matrix tablets

“…This behavior has also been observed for non-modified release dosage forms and should be considered in the validation. 28 In addition, the paddle apparatus at 50 rpm may provide worse hydrodynamics in the dissolution vessel than the basket at 100 rpm. This less effective hydrodynamic is sometimes reported.…”