도베실산칼슘 정 및 아세피필린 정의 용출시험법 개발

• 영문명: Development of the Dissolution Test for Dobesilate Calcium Tablets and Acepifylline Tablets
• 발행기관: 대한약학회
• 저자명: 박찬호(Chan Ho Park) 이진하(Jin Ha Lee) 김은정(Kim Eun Jung) 김동섭(Dong Sup Kim) 김영옥(Young Ok Kim) 손경희(Kyung Hee Sohn) 송영미(Young Me Song) 사홍기(Hong Kee Sah) 최후균(Hoo-Kyun Choi)
• 간행물 정보: 『약학회지』제55권 제2호 (2011년), 131~137쪽, 전체 7쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2011.04.30

영문 초록

The dissolution test method and an analytical procedure by HPLC were developed and validated for dobesilate calcium tablets and acepifylline tablets. These drugs were not yet characterized by the dissolution specifications in Korean Pharmaceutical Codex. So, with each reference and test drugs, we did the preliminary and standard experiments based on the Korean Pharmacopeia Guideline of dissolution testing for solid oral dosage forms. The dissolution test for dobesilate calcium tablets was carried out under sink conditions as following: dissolution medium water, paddle rotation speed 50 rpm and vessel volume 900 ml. More than 90% of its label amount was released within 30 min in this method. Also the dissolution test for acepifylline tablets was carried out under sink conditions as follows: dissolution medium water, paddle rotation speed 100 rpm and vessel volume 900 ml. More than 90% of its label amount was released within 45 min in this method. The dissolution samples were analyzed with a precise and accurate HPLC method. The developed dissolution test showed specificity, linearity, precision and accuracy within the acceptable range. The dissolution testing method described above was adequate for the purpose and may be proposed as a pharmacopeial standard to assess the performance of dobesilate calcium tablets and acepifylline tablets.

키워드

dissolution test dobesilate calcium tablets acepifylline tablets