염산비퀴딜 캡슐 및 알리벤돌 정의 용출시험에 관한 연구

• 영문명: Development of the Dissolution Test for Viquidil Hydrochloride Capsules and Alibendol Tablets
• 발행기관: 대한약학회
• 저자명: 황정분(Joungboon Hwang) 구은주(Eun Joo Koo) 고서연(Seu Youn Go) 조경철(Kyung Chul Cho) 문현주(Hyun-Ju Moon) 조수열(Soo Yeul Cho) 강찬순(Chan Soon Kang) 손여원(Yeo Won Shon) 김영옥(Young Ok Kim) 손경희(Kyung Hee Sohn) 조대현(Dae Hyun Cho)
• 간행물 정보: 『약학회지』제54권 제5호 (2010년), 348~353쪽, 전체 6쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2010.10.31

영문 초록

The dissolution test method and an analytical procedure by HPLC were developed and validated for viquidil hydrochloride capsules and alibendol 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 viquidil hydrochloride capsules was carried out under sink conditions as follows: 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 alibendol 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 viquidil hydrochloride capsules and alibendol tablets.

키워드

dissolution test viquidil hydrochloride capsules alibendol tablets