Reversed phase HPLC method development and validation for the analysis of amlodipine besylate in tablets dosage form and human plasma.


  • Mbang Adeyemi Owolabi Natural Product Laboratory, Department of Pharmaceutical Chemistry, Faculty of Pharmacy, College of Medicine Campus, University of Lagos, Lagos, Nigeria
  • Esther Mojisola Soremi Natural Product Laboratory, Department of Pharmaceutical Chemistry, Faculty of Pharmacy, College of Medicine Campus, University of Lagos, Lagos, Nigeria
  • Olusegun Samson Ajala Natural Product Laboratory, Department of Pharmaceutical Chemistry, Faculty of Pharmacy, College of Medicine Campus, University of Lagos, Lagos, Nigeria


Pharmacokinetics, validation, amlodipine besylate, method development, HPLC


Introduction: Several analytical methods for quantitative determination of amlodipine either in pharmaceuticals or biological fluids have suffered different setbacks. Therefore, we aimed at developing a cost effective, simple, robust, and sensitive reversed phase high performance liquid chromatography (RP-HPLC- UV) method for quantification of amlodipine in dosage form and in human plasma.

Method: The separation was performed on an analytical column 150 mm x 4.6 mm i.d., Agilent Eclipse XDB C18 Column packed with 5 μm particle size and protected by a guard column (30 mm x 4.6 mm i.d.). The mobile phase composition contained acetonitrile: phosphate buffer (25 mM KH2PO4) adjusted to pH 3.1 with orthophosphoric acid in the ratio of 45:55 v/v. The flow rate was 1.2 mL/min and the UV detector was set at a wavelength of 240 nm. The column was maintained at ambient temperature.

Results: The calibration curve gave good linearity in the concentration range studied. The column efficiency was highly evident by high theoretical plates and small height equivalent to theoretical plate (HETP). The percent relative standard deviation (% RSD) was less than 3% in the inter- and intra-day o assay. Amlodipine, 50 ng/mL in plasma stored frozen at -80 C was stable There was no statistical difference in the precision of amlodipine assayed after 12 months when compared to the initial assay (P>0.05). The % recovery of amlodipine in human plasma was 97.79±0.17% to 99.52±0.63%.

 Conclusion: The new RP-HPLC method is sensitive, reproducible, precise, accurate and robust. We conclude that the method is  suitable for estimation of amlodipine besylate in human plasma for pharmacokinetic studies and assay of pharmaceutical dosage  form 



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How to Cite

Owolabi, M. A., Soremi, E. M., & Ajala, O. S. (2023). Reversed phase HPLC method development and validation for the analysis of amlodipine besylate in tablets dosage form and human plasma.: The Nigerian Journal of Pharmacy, 57(2), 774–783. Retrieved from