Pengembangan dan Validasi Metoda Disolusi Tablet Salut Enterik Ketoprofen

Abstract

Ketoprofen enteric-coated tablets are widely marketed in Indonesia, used to manage of the osteo-arthritis, rheumatoid arthritis and also exhibits analgesic and antipyretic activities. But the dissolution test as one of the important parameters to ensure the product quality has not been specifically available in the pharmacopoeia. The purposes of this study were to develop and validate the dissolution test method for enteric-coated ketoprofen tablets. Dissolution profiles were observed for 3 different products at various dissolution test conditions. Dissolution medium chosen were 750 mL HCL 0.1 N for an acidic stage then 1000 mL pH 6.8 and 7.4 phosphate buffer for alkaline stage at stirring rates 50 and 75 rpm using USP apparatus 2 (paddle) and 75 rpm using USP apparatus 1 (basket). The amount of ketoprofen released was determined by UV-spectrophotometry. The dissolution test method of deaerated 1000 mL pH 6.8 phosphate buffer at stiring rate 75 rpm using USP apparatus 1 showed as hyperdiscriminating method at the value of Q45≥75%. The validation of the selected dissolution test method meets the acceptance criteria of the specificity, linearity (r = 0.9988), precision (relative standard deviation = 1.12%) and accuracy (recovery = 95.7 - 97.6%). The dissolution test developed and validated was adequate for its purposes and could be applied for quality control of ketoprofen enteric coated tablets.