Abstract

Tablet splitting has been a practice widely used. The aim of this work is to investigate the influence of splitting on content uniformity of 25 mg captopril tablets, a common dosage form. Split tablets were obtained by using the hands, a knife or a tablet-splitter. Captopril reference product and two different brands codified as X and Y were used in this study. The method used for quantification was that described in The United States Pharmacopoeia, 30th ed. The results showed that the quality of the analyzed products was affected by splitting processes (by either using the hands, a knife or a tabletsplitter). Nevertheless, the use of tablet splitter produced halves more uniform than the other division processes considered. Moreover, similar products codified as X and Y had a greater discrepancy in content uniformity when knife was used to split the tablets, while splitting the tablets by hands produced the highest variation in the reference product. Considering that lack of information about the split tablets can result in an inadequate therapy, problems related to captopril tablet splitting could be minimized by the distribution of splitting devices.

Keywords: Captopril, content uniformity, pharmaceutical quality control, tablet splitting, tablet-splitter, High performance liquid chromatography