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片剂制剂中左旋三碘甲状腺原氨酸钠和左甲状腺素钠的反相高效液相色谱分析:溶出度和含量均匀度的初步研究

Reversed-phase high-performance liquid chromatographic analysis of liothyronine sodium and levothyroxine sodium in tablet formulations: preliminary studies on dissolution and content uniformity.

作者信息

Rapaka R S, Knight P W, Prasad V K

出版信息

J Pharm Sci. 1981 Feb;70(2):131-4. doi: 10.1002/jps.2600700205.

Abstract

Levothyroxine sodium was estimated from tablet formulations of levothyroxine sodium and liotrix (liothyronine sodium-levothyroxine sodium combination tablet). The procedures consisted of the addition of 3,3-,5-triiodothyronine as the internal standard to the pulverized sample, followed by an acidic butanol extraction, evaporation, and injection onto a muBondapak reversed-phase high-performance liquid chromatographic column. The eluent was methanol-water-phosphoric acid (50:50:0.1), and the effluent was monitored by UV detection at 254 nm. A standard linear calibration curve was obtained for direct standard solutions equivalent to 18-225 micrograms of levothyroxine sodium/tablet. The procedure is sensitive enough for single-tablet analysis. Using this procedure, content uniformity studies were performed on liothyronine sodium tablets, levothyroxine sodium tablets, and liotrix tablets. The procedure also was adapted for conducting dissolution studies on levothyroxine sodium tablets in deionized water using the rotating-paddle method.

摘要

从左甲状腺素钠片制剂和左旋甲状腺素 - 碘塞罗宁(碘塞罗宁钠 - 左甲状腺素钠复方片)中测定左甲状腺素钠。实验步骤包括:向粉碎后的样品中加入3,3',5 - 三碘甲状腺原氨酸作为内标,接着进行酸性丁醇萃取、蒸发,然后注入μBondapak反相高效液相色谱柱。洗脱液为甲醇 - 水 - 磷酸(50:50:0.1),流出物通过254nm的紫外检测进行监测。对于相当于每片含18 - 225微克左甲状腺素钠的直接标准溶液,得到了标准线性校准曲线。该方法对于单片分析灵敏度足够。使用此方法,对碘塞罗宁钠片、左甲状腺素钠片和左旋甲状腺素 - 碘塞罗宁片进行了含量均匀度研究。该方法还适用于采用转桨法对左甲状腺素钠片在去离子水中进行溶出度研究。

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