YAKHAK HOEJI (약학회지)

The Pharmaceutical Society of Korea (대한약학회)
권호 표지

Development of Dissolution Test Method for Buflomedil Hydrochloride Tablets and Ticlopidine Hydrochloride Tablets

염산부플로메딜 정과 염산티클로피딘 정의 용출시험법 개발

  • Lee, Ryun-Kyung (Hazardous Substances Analysis Division, Daegu regional Korea Food & Drug Administration) ;
  • Jeong, Gyeong-Rok (Hazardous Substances Analysis Division, Daegu regional Korea Food & Drug Administration) ;
  • Oh, Hyun-Sook (Hazardous Substances Analysis Division, Daegu regional Korea Food & Drug Administration) ;
  • Shim, Jee-Youn (Hazardous Substances Analysis Division, Daegu regional Korea Food & Drug Administration) ;
  • Suh, Sang-Chul (Hazardous Substances Analysis Division, Daegu regional Korea Food & Drug Administration) ;
  • Lee, Hyo-Jung (Hazardous Substances Analysis Division, Daegu regional Korea Food & Drug Administration) ;
  • Kim, Min-A (Hazardous Substances Analysis Division, Daegu regional Korea Food & Drug Administration) ;
  • Park, Seong-Min (Hazardous Substances Analysis Division, Daegu regional Korea Food & Drug Administration) ;
  • Lee, Kyu-Ha (National Institute of Food and Drug Safety Evaluation, Osong Health Technology Administration Complex) ;
  • Sohn, Kyung-Hee (National Institute of Food and Drug Safety Evaluation, Osong Health Technology Administration Complex) ;
  • Kim, In-Kyu (National Institute of Food and Drug Safety Evaluation, Osong Health Technology Administration Complex) ;
  • Sah, Hong-Kee (College of Pharmacy, Ewha Womans University) ;
  • Choi, Hoo-Kyun (College of Pharmacy, Chosun University) ;
  • Cho, Tae-Yong (Hazardous Substances Analysis Division, Daegu regional Korea Food & Drug Administration) ;
  • Hong, Choong-Man (Hazardous Substances Analysis Division, Daegu regional Korea Food & Drug Administration)
  • 이륜경 (대구지방식품의약품안전청 유해물질분석과) ;
  • 정경록 (대구지방식품의약품안전청 유해물질분석과) ;
  • 오현숙 (대구지방식품의약품안전청 유해물질분석과) ;
  • 심지연 (대구지방식품의약품안전청 유해물질분석과) ;
  • 서상철 (대구지방식품의약품안전청 유해물질분석과) ;
  • 이효정 (대구지방식품의약품안전청 유해물질분석과) ;
  • 김민아 (대구지방식품의약품안전청 유해물질분석과) ;
  • 박성민 (대구지방식품의약품안전청 유해물질분석과) ;
  • 이규하 (식품의약품안전평가원 의약품규격연구과) ;
  • 손경희 (식품의약품안전평가원 의약품규격연구과) ;
  • 김인규 (식품의약품안전평가원 의약품규격연구과) ;
  • 사홍기 (이화여자대학교 약학대학) ;
  • 최후균 (조선대학교 약학대학) ;
  • 조태용 (대구지방식품의약품안전청 유해물질분석과) ;
  • 홍충만 (대구지방식품의약품안전청 유해물질분석과)
  • Received : 2011.09.21
  • Accepted : 2012.08.23
  • Published : 2012.08.31
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Abstract

Drug dissolution test has been used for the purpose of both quality control of solid oral dosage forms and predicting in vivo drug release profiles. In this study, the dissolution profiles of buflomedil hydrochloride tablets and ticlopidine hydrochloride tablets were investigated according to the "Guidelines on Specifications of Dissolution tests for Oral dosage forms" of Korean Pharmacopoeia (KP). The analytical method using HPLC was validated. The validation was performed in terms of specificity, linearity, accuracy, precision and limit of quantitation.

Keywords

References

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