#TITLE_ALTERNATIVE#

• Main Author: ODE MUHAMMAD JUNIARDIN (NIM 10701100), LA
• Format: Final Project
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/10790
• Institution: Institut Teknologi Bandung

Comparative dissolution test was needed as a complement of bioequivalent test or substitution of bioequivalent test for a lower potency dosage form. Comparative dissolution test differs from compendial dissolution test in sampling times. Comparative dissolution test uses several sampling times. Sometimes, the result of comparative dissolution test was not the same as the result of common dissolution test. The purpose of this research was to observe the quality of metronidazole tablets of different strength from dissolution point of view. Comparative dissolution test was done by using the condition for compendial dissolution test stated in FI IV which is in HCl 0.1 N pH 1.2, and also in citrate buffer pH 4.5 and phosphate buffer pH 6.8. Tablet samples as test object were obtained from market (250 mg and 500 mg). Several generic metronidazole 500 mg tablet tested in this study did not fulfill the requirements stated in FI IV, but were similar to reference product. In citrate buffer pH 4.5, one of generic product was not similar to reference product, while in phosphate buffer pH 6.8, all generic product were similar to reference product. For generic tablet with lower dose (250 mg), the use of two units (same dose) in dissolution test gave similar result as the higher dose (500 mg). Meanwhile, the use of one unit gave dissimilar result.