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KMID : 0370220110550020131
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Yakhak Hoeji
2011 Volume.55 No. 2 p.131 ~ p.137
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Development of the Dissolution Test for Dobesilate Calcium Tablets and Acepifylline Tablets
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Park Chan-Ho
Lee Jin-Ha
Kim Eun-Jung
Sohn Kyung-Hee
Kim Young-Ok
Kim Dong-Sup
Song Young-Mi
Sah Hong-Kee
Choi Hoo-Kyun
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Abstract
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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.
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KEYWORD
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dissolution test, dobesilate calcium tablets, acepifylline tablets
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