YAKHAK HOEJI (약학회지)

The Pharmaceutical Society of Korea (대한약학회)
권호 표지

Development of the Dissolution Tests for Nafronyl Oxalate Capsules and Tramadol Hydrochloride Capsules

수산나프로닐 캡슐 및 염산트라마돌 캡슐의 용출시험에 관한 연구

  • Hwang, Joung-Boon (Gyeongin Regional Food and Drug Administration, Hazardous Substances Analysis Division) ;
  • Moon, Hyun-Ju (Gyeongin Regional Food and Drug Administration, Hazardous Substances Analysis Division) ;
  • Go, Seo-Youn (Gyeongin Regional Food and Drug Administration, Hazardous Substances Analysis Division) ;
  • Jang, Gi-Uk (Gyeongin Regional Food and Drug Administration, Hazardous Substances Analysis Division) ;
  • Lee, Kyu-Ha (National Institute of Food and Drug Safety Evaluation, Pharmaceutical Standardization Research and Testing Division) ;
  • Sohn, Kyung-Hee (National Institute of Food and Drug Safety Evaluation, Pharmaceutical Standardization Research and Testing Division) ;
  • Kim, In-Kyu (National Institute of Food and Drug Safety Evaluation, Pharmaceutical Standardization Research and Testing Division) ;
  • Cho, Dae-Hyun (Gyeongin Regional Food and Drug Administration, Hazardous Substances Analysis Division)
  • 황정분 (경인지방식품의약품안전청 유해물질분석과) ;
  • 문현주 (경인지방식품의약품안전청 유해물질분석과) ;
  • 고서연 (경인지방식품의약품안전청 유해물질분석과) ;
  • 장기욱 (경인지방식품의약품안전청 유해물질분석과) ;
  • 이규하 (식품의약품안전평가원 의약품규격연구과) ;
  • 손경희 (식품의약품안전평가원 의약품규격연구과) ;
  • 김인규 (식품의약품안전평가원 의약품규격연구과) ;
  • 조대현 (경인지방식품의약품안전청 유해물질분석과)
  • Received : 2011.06.30
  • Accepted : 2011.08.08
  • Published : 2011.10.31
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Abstract

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.

Keywords

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