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수산나프로닐 캡슐 및 염산트라마돌 캡슐의 용출시험에 관한 연구
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  • 수산나프로닐 캡슐 및 염산트라마돌 캡슐의 용출시험에 관한 연구
저자명
황정분,문현주,고서연,장기욱,이규하,손경희,김인규,조대현,Hwang. Joung-Boon,Moon. Hyun-Ju,Go. Seo-Youn,Jang. Gi-Uk,Lee. Kyu-Ha,Sohn. Kyung-Hee,Kim. In-Kyu
간행물명
약학회지
권/호정보
2011년|55권 5호|pp.411-418 (8 pages)
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대한약학회
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

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.