YAKHAK HOEJI (약학회지)

The Pharmaceutical Society of Korea (대한약학회)
권호 표지

Development of the Dissolution Test for Dobesilate Calcium Tablets and Acepifylline Tablets

도베실산칼슘 정 및 아세피필린 정의 용출시험법 개발

  • Park, Chan-Ho (Hazardous Substances Analysis Division, Gwangju Regional Food and Drug Administration) ;
  • Lee, Jin-Ha (Hazardous Substances Analysis Division, Gwangju Regional Food and Drug Administration) ;
  • Kim, Eun-Jung (Hazardous Substances Analysis Division, Gwangju Regional Food and Drug Administration) ;
  • Sohn, Kyung-Hee (National Institute of Food and Drug Safety Evaluation) ;
  • Kim, Young-Ok (National Institute of Food and Drug Safety Evaluation) ;
  • Kim, Dong-Sup (National Institute of Food and Drug Safety Evaluation) ;
  • Song, Young-Me (Korea Food and Drug Administration, Bioequivalence Evaluation Divison) ;
  • Sah, Hong-Kee (College of Pharmacy, Ewha Womans University) ;
  • Choi, Hoo-Kyun (College of Pharmacy, Chosun University)
  • 박찬호 (광주지방식품의약품안전청 유해물질분석과) ;
  • 이진하 (광주지방식품의약품안전청 유해물질분석과) ;
  • 김은정 (광주지방식품의약품안전청 유해물질분석과) ;
  • 손경희 (식품의약품안전평가원) ;
  • 김영옥 (식품의약품안전평가원) ;
  • 김동섭 (식품의약품안전평가원) ;
  • 송영미 (식품의약품안전청 약효동등성과) ;
  • 사홍기 (이화여자대학교 약학대학) ;
  • 최후균 (조선대학교 약학대학)
  • Received : 2011.02.10
  • Accepted : 2011.03.21
  • Published : 2011.04.30
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Abstract

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.

Keywords

References

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