Development and Validation of highly Sensitive Stability Indicating Spectrofluorimetric Method for Determination of Amlodipine in Pharmaceutical Preparations and Human Plasma

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• 作者：Abdel-Maaboud I. Mohamed ; Mahmoud A. Omar ; Mohamed A. Hammad…
• 关键词：Amlodipine ; Spectrofluorimetry ; Pharmaceutical formulations ; Spiked human plasma ; Stability ; indicating
• 刊名：Journal of Fluorescence
• 出版年：2016
• 出版时间：November 2016
• 年：2016
• 卷：26
• 期：6
• 页码：2141-2149
• 全文大小：663 KB
• 刊物类别：Biomedical and Life Sciences
• 刊物主题：Biomedicine
  Biomedicine
  Biophysics and Biomedical Physics
  Biotechnology
  Biochemistry
  Analytical Chemistry
  
• 出版者：Springer Netherlands
• ISSN：1573-4994
• 卷排序：26

文摘

A highly sensitive and simple spectrofluorimetric method was developed for the determination of Amlodipine besylate (AML) in its pharmaceutical formulations and spiked human plasma. The proposed method is based on the investigation of the fluorescence spectral behaviour of AML in Tween-80 micellar system. In aqueous solution, the fluorescence intensity of AML was greatly enhanced (160 %) in the presence of Tween-80. The fluorescence intensity was measured at 427 nm after excitation at 385 nm. The fluorescence–concentration plot was rectilinear over the concentration range 0.1–4.0 μg/ml, with lower detection limit of 0.03 μg/ml. The suggested method was successfully applied for the analysis of AML in its commercial tablets alone or in combination with either Atorvastatin or Valsartan. The application of the proposed method was extended to the assay of AML in spiked human plasma and stability studies of AML after exposure to different forced degradation conditions, such as acidic, alkaline, photo- and oxidative conditions, according to ICH guidelines. The results were statistically compared to those obtained by comparison methods and were found to be in good agreement.