Extended release tablets containing co-processed dry binders and tramadol hydrochloride – determination of the content uniformity

Abstract

An automated method for the extended release tablet processing and determination of tramadol hydrochloride in matrix tablets containing coprocessed dry binders has been developed by using a bench-top robotic system connected with HPLC system. The automated operations include (i) disintegration steps of the dosage form, (ii) homogenisation, (iii) setting time, (iv) filtration, (v) dilution, and (vi) injection of a sample into the HPLC vials or chromatographic system. The method developed has been optimized and validated; recoveries of spike tests being found in the range of 97.8-99.6 %. The relative standard deviation representing the precision of the method was 1.02 % for tramadol hydrochloride in tablets with DisintequikTM MCC 25 and 1.15 % for tramadol hydrochloride in tablets with Prosolv® SMCC 90. The validated method was applied to the determination of the target substance in samples of two commercial pharmaceutical formulations: Tralgit SR 100 and Tramadol Retard Actavis 100 mg.