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

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)
Publication Information
YAKHAK HOEJI / v.55, no.2, 2011 , pp. 131-137 More about this Journal
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
dissolution test; dobesilate calcium tablets; acepifylline tablets;
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