Abstract

The objective of this study was to comparatively assess the quality of generic Telmisartan tablets with the brand. Mean drug content and impurities determination, dissolution tests and solubility tests in four different media were performed on ten Telmisartan generics and the brand Micardis. High performance liquid chromatography was used in the determination of Telmisartan content, impurities and solubility of Telmisartan in the tablets and dissolution apparatus II was used for dissolution tests. Four generics showed poor solubility and dissolution rate in water, pH 7.5 and pH 4.5; three of them having a relatively huge number of impurities compared to the brand. The other six generics showed more or less the same mean drug content, dissolution rate as that of the brand and a better solubility. Three generics showed to have a comparable number and amount of impurities as that of the brand. The dissolution profiles of four generics were comparable to that of the brand in two different dissolution media out of the four media used in the dissolution tests. This study showed that while some generics may be of inferior quality to that of their brand counterparts, others can be of approximately the same quality as that of the brand.

Key words: Brand, generic, Telmisartan, dissolution, impurities, quality.