Comparative Dissolution Studies of Marketed Preparations and Treatment of Data by Using ANOVA

Various brands of same dosage forms are available in the market with the common claim that they are all bioequivalent. The main objective of present study was to conduct the comparative dissolution studies of various brands of same dosage form and treatment of dissolution data obtained by using Analysis of Variance (ANOVA) to determine whether all the formulations used were equivalent or significantly different. Six different brands of paracetamol 500 mg conventional tablets from different manufacturers were selected in the study and dissolution testing in 7.8 pH phosphate buffer was conducted for 6 tablets from each brand for 30 min by using electrolab automated dissolution testing apparatus USP type-II, samples were withdrawn at every 5 min time interval and analyzed for drug content by using UV/VIS double beam spectrophotometer. Percent drug release at each time interval was calculated for total 36 tablets (6X6) and the data obtained was treated with statistical technique –ANOVA. It was concluded from the study that all the formulations were equivalent and there was no intra and inter variation between each and every formulation. Keywords: Dissolution, Drug release, ANOVA, Phosphate Buffer