UJI MUTU FISIK TABLET DAN DISOLUSI TERBANDING TABLET OFLOKSASIN GENERIK DENGAN INOVATOR

Comparative dissolution test is dissolution test performed to show the similarity of dissolution profiles between test drugs and innovator drugs. The test is important to know or provide information on the dissolution profile equality between the innovator and the test drugs. BPOM requires comparative dissolution test based on Biopharmaceutic Classification System (BCS). Drugs that must be tested with comparative dissolution is ofloxacin. The purpose of this research is to know the similarity of dissolution profile and physical quality of generic ofloxacin tablet with innovator. Dissolution test of ofloxacin tablet using dissolution tool type 2 (paddle), rotation speed 50 rpm in 900 mL dissolution HCl pH 1,2 medium. Determination of dissolution rate using UV-Visible spectrophotometer at 294 nm wavelength. The test product used five ofloxacin 200 mg tablets on the market, ie 1 A innovator branded, 2 B and C branded, and 2 D and E generic product. The results of physical quality test of five products meet the requirements and provisions of good tablets. The dissolution profile of the test product shows the similarity of the dissolution profile of the innovator product, seen from the F1 parameter less than 15% and the F2 parameter above 50%. Test products and innovators fulfill the requirements of Pharmacope Indonesia edition III and United States Phamacopeia edition 32 Keywords : ofloxacin, physical quality test, comparative dissolution test