Dissolution test and comparison of in vitro dissolution profiles of amlodipine tablets (reference, generic and similar) marketed in Bahia, Brazil using factorial design

Vol. 1, 2019. - 116719
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Amlodipine, used to treat arterial hypertension1, requires essential pharmacopoeial testing for quality assurance2. Objective: To evaluate the dissolution kinetics of amlodipine tablets. Methods: Tests were performed3 (weight uniformity, friability and disintegration); a dissolution method was developed, using factorial design 23 (rotation, HCl concentration and medium volume); within 30 min at 37±0.5 °C and USP apparatus 2 (paddle)4 and to validated according to RDC 166/201755. Results: Analysis of variance (ANOVA) and Paretto (Statistica7.0) showed that variables did not significantly affect drug release; and minimum conditions (50rpm and 500mL of 0.001mol L-1 HCl) were used to delineate dissolution profiles (1-60min)4 in different media: distilled water (pH = 6.03); acetate buffer (pH = 4.5) and borate buffer (pH = 8.0), with major release of amlodipine in acidic medium. Dissolution efficiencies were calculated: reference (73.6%), generic (61.3%) and similar (59.1%). Conclusion: Amlodipine tablets complied with pharmacopoeial tests, with method fast, linear and accurate.

  • 1 Universidade do Estado da Bahia
Factorial Design