Abstract
This work developed a methodology that can potentially be applied to the quality control of cimetidine drug substance and its tablets. The kT obtained at different temperatures (200, 190, 180, 170 and 160°C) were determined by isothermal thermogravimetric method using the classical Arrhenius equations. The dissolution profiles were obtained using USP 24 (Method 711) and rate constants (kD) were determined by Kitazawa equations. An evaluation was made to check if there was statistically significant correlation between the two variables kT and kD. Isothermal TG data were used to determine the reaction order and degradation reaction rate constants. The results showed that in all temperatures thermal order (kT) was: C<A<B tablets, while dissolution order (kD) was: C<A<B tablets. In conclusion, correlation between kT/kD seems to be a suitable method for detecting possible interactions between cimetidine and excipients in development or manufacturing changes, particularly for immediate release dosage forms and therefore could be especially useful on quality control.
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