ジクロフェナックナトリウム製剤の品質と純度

概要

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The relationship between in-vitro pharmaceutical properties and bioavailability of commercially available diclofenac sodium was described in the previous paper showing results of our general pharmaceutical tests and determination of the concentration in human plasma. Further studies were conducted this time to detect residual organic solvents in drugs, to measure the quantity of diclofenac by the ultraviolet absorption method, and to make quantitative analysis of diclofenac by atomic absorption spectrophotometry. The quantitative values of the diclofenac preparations tested were in agreement with one exception where the value was very low. On the other hand, the atomic absorption spectrophotometry study showed that some of the products contained approximately 30% of potassium salt although they were labelled sodium salt. Furthermore, the gas chromatography study showed the presence of 100 ppm or more ethanol and/or isopropanol residuals in several products.
日本医療薬学会の論文
1983-10-20