이토프리드염산염 정과 티로프라미드염산염 정의 용출시험법 개발

Development of Dissolution Test for Itopride Hydrochloride Tablets and Tiropramide Hydrochloride Tablets

Dissolution test has been performed to control drug quality and to predict in vivo drug release profile of solid dosage forms, so there's a drift towards setting dissolution test instead of disintegration test. However, some solid dosage forms in Korea Pharmaceutical Codex (KPC) are not established the dissolution test yet, so these monographs are necessary to set the specification of dissolution test. In this study, we developed the specification and test method of dissolution test for itopride hydrochloride tablets and tiropramide hydrochloride tablets which are not established the dissolution test yet. According to the 「Manual for Guideline Application for Validation of Analytical Procedures」 and 「Guidelines on Spec- ification of Dissolution test for Oral dosage form」 of Korean harmacopoeia (KP), we validated and established each devel- opment method. Based on the preliminary dissolution profile, we set the dissolution condition(paddle apparatus, pH 1.2 media, 50 rpm). For this condition, we performed the main dissolution test to determine the specification (45 min, 85%). Finally, we validated each analytical method by specificity, linearity, accuracy and precision. These developed methods will be included the next supplement of KPC and also contributed to the quality control of medicines.