• YAKHAK HOEJI
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• v.44 no.5
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• pp.406-410
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• 2000

The present method is to describe a potentiometric norfloxacin electrode system characterized by a membrane, based on the use of norfloxacin (NF) complex with ion-association reagents. These complexes were dissolved in DMSO, DMF acetonitrile or acetone and dispersed in plasticized poly(vinyl chloride) matrix. The picric acid complex electrode exhibited near-Nernstian response for NF in acetate buffer solution (pH 4.0) with a slope of 53.03 mV/decade. And linear response over the range of 10$^{-5}$ to 10$^{-3}$M solution of NE. The ingredients in tablet, capsule and biological important organic acids were not interfere.

• YAKHAK HOEJI
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• v.54 no.5
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• pp.362-369
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• 2010

Despite the fact that the dissolution test can serve as an effective tool for drug quality control and prediction of in vivo drug performance, there are a number of drugs with no established dissolution specifications because they were developed quite a long time ago. Under this circumstances, KFDA started the new project that establishes dissolution method and specifications for drugs with no dissolution specifications listed in the Korea Pharmaceutical Codex (KPC). This project aims for promoting the appropriate management of oral solid dosage forms. Seoul regional KFDA selected 2 items, Nicametate citrate tablet and Norfloxacin capsule, for establishing dissolution specifications. We went through the following procedures to develop the dissolution method and specifications: (1) Validation of dissolution test equipment, (2) Purchase of test drugs, (3) Preliminary test with one of the test products (1 lot), (4) Validation of analysis methods (3 lots), (5) Final tests and cross tests among other laboratory to establish dissolution specifications, (6) Additional test with the other test drugs. The outcome of this study will be reflected in revision of the KPC. It is believed that the quality control and evaluation of oral solid dosage forms listed in KPC will be advanced with the revision which adds additional dissolution test and specifications for the drugs with no established dissolution specifications.