수산나프로닐 캡슐 및 염산트라마돌 캡슐의 용출시험에 관한 연구

• 영문명: Development of the Dissolution Tests for Nafronyl Oxalate Capsules and Tramadol Hydrochloride Capsules
• 발행기관: 대한약학회
• 저자명: 황정분(Joung-Boon Hwang) 문현주(Hyun-Ju Moon) 고서연(Seo Youn Go) 장기욱(Gi-Uk Jang) 이규하(Kyu Ha Lee) 손경희(Kyung Hee Sohn) 김인규(In-Kyu Kim) 조대현(Dae Hyun Cho)
• 간행물 정보: 『약학회지』제55권 제5호 (2011년), 411~418쪽, 전체 8쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2011.10.31

영문 초록

The dissolution test method and an analytical procedure by HPLC were developed and validated for nafronyl oxalate capsules and tramadol hydrochloride capsules. These drugs were not yet characterized by the dissolution specifications in the 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 nafronyl oxalate capsules was carried out under sink conditions as follows: dissolution medium phosphate buffer pH 6.8, paddle rotation speed 100 rpm and vessel volume 900 ml. More than 80% of its label amount was released within 30 min in this method. Also the dissolution test for tramadol 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 15 min in this method. The dissolution samples were analyzed with a validated HPLC analytical procedure. The analytical methodology showed acceptable values in terms of specificity, linearity, precision and accuracy. The dissolution test methods described above were adequate for the purpose and may be proposed as a pharmacopeial standard to assess the performance of nafronyl oxalate capsules and tramadol hydrochloride capsules. Furthermore, the outcomes of this study were expected to help create an environment where safe and high quality drugs would be distributed on the domestic market making contributions to advancing public health.

키워드

dissolution test nafronyl oxalate capsules tramadol hydrochloride capsules