ACTA FAC MED NAISS 2021;38(2): 147-155

Original article

Spectrophotometric Method in Comparative In Vitro Dissolution Test of Branded
and Generic Ibuprofen Tablets

Ana Marković¹, Miroslava Spasić¹, Vesna Savić¹, Slavica Sunarić², Marija Tasić Kostov¹

¹University of Niš, Faculty of Medicine, Department of Pharmacy, Niš, Serbia
²University of Niš, Faculty of Medicine, Department of Chemistry, Niš, Serbia

SUMMARY

                    The dissolution test is a simple and important in vitro method for assessing the bioequivalence, which aims to compare the bioavailability of generic and branded drugs. It implies the use of a proper apparatus (usually pharmacopoeially defined) in which the dosage form is dissolved, and the dissolution process itself is monitored/quantified using an appropriate analytical method among which high-performance liquid chromatography (HPLC) is widely used. Spectrophotometry could be a significant substitute, through its advantages in terms of simplicity and costs of analysis. In the present study, possible differences in bioavailability between branded and generic ibuprofen coated tablets were predicted using a dissolution test for solid dosage forms. The ibuprofen content and the amount of ibuprofen released in the dissolution test were determined using a simple spectrophotometric method. Based on the obtained results, no significant differences in the dissolution rate of ibuprofen from generic and branded coated tablets were observed. It can be concluded that the spectrophotometric method applied for the dissolution test, among other suitable methods, could be used for bioequivalence screening in conditions where rapid and simple assessment is required or where HPLC method is not available.

Key words: dissolution test, ibuprofen, bioequivalence, generic drug, branded drug