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高效液相色谱法同时测定药物制剂中琥珀酸美托洛尔和苯磺酸氨氯地平的含量

Simultaneous determination of metoprolol succinate and amlodipine besylate in pharmaceutical dosage form by HPLC.

作者信息

Dongre Vaijanath G, Shah Sweta B, Karmuse Pravin P, Phadke Manisha, Jadhav Vivek K

机构信息

Department of Chemistry, University of Mumbai, Vidyanagari, Kalina, Santacruz (East), Mumbai 400098, India.

出版信息

J Pharm Biomed Anal. 2008 Feb 13;46(3):583-6. doi: 10.1016/j.jpba.2007.11.006. Epub 2007 Nov 17.

Abstract

A simple, precise, specific and accurate reverse phase HPLC method has been developed for the simultaneous determination of metoprolol succinate (MS) and amlodipine besylate (AB) in tablet dosage form. The chromatographic separation was achieved on Hypersil BDS cyano (250 mm x 4.6 mm, 5 microm) column using PDA detector. The mobile phase consisting of buffer (aqueous triethylamine pH 3) and acetonitrile in the ratio of 85:15 (v/v) at a flow rate of 1.0 mL/min was used. The method was validated according to the ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness.

摘要

已开发出一种简单、精确、特异且准确的反相高效液相色谱法,用于同时测定片剂剂型中的琥珀酸美托洛尔(MS)和苯磺酸氨氯地平(AB)。使用PDA检测器,在Hypersil BDS氰基柱(250 mm×4.6 mm,5微米)上实现色谱分离。流动相由缓冲液(pH 3的三乙胺水溶液)和乙腈按85:15(v/v)的比例组成,流速为1.0 mL/min。该方法根据ICH指南在特异性、线性、准确性、精密度和稳健性方面进行了验证。

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