Abstract

The aim of the present work was to develop a RP - HPLC method for simultaneous separat ion of Metoprolol and Amlodipine and validate the developed method for quantitative determination o f the above said drugs in combination tablet dosage form. A simple, rapid, validated chromatographic method was developed for s eparation and determination of metopr olol and amlodipine in tablet preparations. The anti - hypertensive agents were separated usin g Welchrom RP - C 18 Column (4.6 mm X 250 mm, 5 µ), Shimadzu LC - 20 AT Promi nence Liquid Chromatograph and the mobile phase constituted of 10 mM Phosphate buffer (pH 3.0): acetonitrile (50:50, v/v). The flow rate was 1.0 mL/min and the analyses were performed using Shimadzu SPD - 20A Prominence UV - Visible detector at 235 nm. T he separation of the anti - hypertensive agents, Metopro lol and Amlodipine was achieved within 5 min utes . Metoprolo l and Amlodipine eluted at retention times of 2.690 min utes and 3.797 min utes respectively. The drugs obey ed Beer’s law in the concentration range of 5 - 25 µg/mL for metopro lol and 1 - 5 µg/mL for amlodipine. The developed assay method was found to be selective, precise and accurate. The method has been successfully applied for de termination of Metopro lol and Amlodipine in pharmaceutical combination tablet dosage form. This developed method is sensitive, fast, and simple with excellent peak symmetry and high resolution.

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