Quality Test of Commercial Ubidecarenone Tablets

Abstract

The quality of 10 kinds of ubidecarenone tablets commercially available from 6 pharmaceutical companies was evaluated on dissolution, weight variation, disintegration and content uniformity. Ubidecarenone is insoluble in hydrophilic solutions such as the 1st fluid specified in J. P. X, which are commonly used as dissolution media, and easily soluble in alcoholic solutions.The authors developed a method of a new dissolution test consisting of the following two steps: 1) Disintegration step: 70 ml of the 1st fluid was placed in the vessel (U. S. P. XIX). The paddle (J. P. X) was assembled so that there is a distance of O.5 cm between the paddle and the bottom of the vessel. One tablet was placed in the vessel and the paddle was rotated at 100 rpm for 10 min (plain tablet) and 60 min (sugar coated tablet). 2) Dissolution step: Immediately after 830 ml of 99.5% ethanol was added, 10 ml each of specimens was withdrawn at certain intervals and the contents of ubidecarenone dissolved was determined by photometry. 50% dissolution time (T50) and dissolution rate at T50 were obtained from each dissolution curve plotted using the mean values (n= 6).The variations in dissolution rates (more than 90 to 3%/ min) and T50 (0.5 to 10 min) were observed among the samples. Disintegration times of the plain tablets and of the sugar coated tablets varied from 0.2 to 14.2 min and from 7.4 to 20.9 min, respectively. No significant difference in weight variation (0.5 to 4.6%) and content (96 to 106%) was observed among the samples.