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药物溶出度的无创极谱测量法

Noninvasive polarographic measurement of drug dissolution.

作者信息

Hackman M R, Brooks M A

出版信息

J Pharm Sci. 1978 Jun;67(6):842-7. doi: 10.1002/jps.2600670631.

Abstract

Polarographic analysis was applied successfully to dissolution studies and content uniformity assessment of both capsules and tablets, using a dropping mercury electrode with the modified Levy beaker method. The described noninvasive technique places the polarographic sensor probe directly into the dissolution flask and thus simplifies dissolution measurement by eliminating transfer lines and pumps typically required with the invasive (sampling) mode of analysis. A continuous sampling flowcell with polarographic detection was also evaluated for invasive measurements. Continuous dissolution profiles and content uniformity were determined for chlordiazepoxide, trimethoprim, ornidazole, and isoniazid, using the invasive and noninvasive sampling modes. Results obtained for these drugs showed excellent precision with both sampling techniques. In addition, excellent correlation to UV spectrophotometric data was obtained.

摘要

采用改良的利维烧杯法,使用滴汞电极,极谱分析法成功应用于胶囊和片剂的溶出度研究及含量均匀度评估。所描述的非侵入性技术将极谱传感器探头直接放入溶出度烧瓶中,从而通过消除侵入性(取样)分析模式通常所需的传输线和泵,简化了溶出度测量。还评估了用于侵入性测量的带有极谱检测的连续进样流通池。使用侵入性和非侵入性取样模式,测定了氯氮卓、甲氧苄啶、奥硝唑和异烟肼的连续溶出曲线和含量均匀度。这两种取样技术对这些药物获得的结果均显示出极佳的精密度。此外,与紫外分光光度数据具有良好的相关性。

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