Weight and content uniformity of warfarin sodium half tablets

摘要

This study aims at investigating drug content and weight of the split half tablet using tablet splitter, hand, and knife for warfarin. Warfarin sodium tablets 5 mg (brand A, brand B, brand C, brand D) were studied, and Weight variation and drug content were analyzed for warfarin sodium in 0.1N NaOH using spectrophotometer. The percentages of each whole tablet’s or half-tablet’s drug content and weight difference from sample mean values were compared with USP specification ranges. All whole tablets and half tablets when tablet splitter was used meet the USP specification for weight and drug content,while half tablets when hand and knife were used fail to meet the USP specification for weight and drug content. The % RSDs for drug content and weight meet the USP specification for whole warfarin sodium tablets and the half tablets which were split by tablet splitter, while halves which were split by hand and knife don't.