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Updated: Sep 20, 2025

An Integrated Raman Spectroscopy and Mass Spectrometry Platform to Study Single-Cell Drug Uptake, Metabolism, and Effects
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Different Approaches in Manipulating Ratio Spectra for Analyzing Amlodipine Besylate and Irbesartan Combination

Dina A El Mously1, Nadia M Mostafa1, Nagiba Y Hassan1

  • 1Cairo University, Faculty of Pharmacy, Analytical Chemistry Department, Kasr-El-Aini St, 11562 Cairo, Egypt.

Journal of AOAC International
|June 11, 2022
PubMed

Insights

Sensitive spectrophotometric methods were developed for simultaneously determining amlodipine besylate and irbesartan. These cost-effective techniques are suitable for routine quality control analysis in laboratories.

Area of Science:

  • Analytical Chemistry
  • Pharmaceutical Analysis

Background:

  • Hypertension is a significant risk factor for cardiovascular diseases like ischemic heart disease and atherosclerosis.
  • Combination therapy with drugs like amlodipine besylate (AML) and irbesartan (IRB) is often necessary for effective blood pressure control.
  • AML (calcium channel blocker) and IRB (angiotensin receptor blocker) demonstrate synergistic antihypertensive activity.

Purpose of the Study:

  • To develop sensitive spectrophotometric methods for the simultaneous determination of amlodipine besylate and irbesartan.
  • To provide efficient analytical tools for quality control of these commonly prescribed antihypertensive drugs.

Main Methods:

  • Three spectrophotometric methods based on ratio spectra manipulation were employed: ratio difference, mean centering of ratio spectra, and derivative ratio.
  • These methods facilitate the simultaneous assay of AML and IRB mixtures.

Main Results:

  • The developed methods achieved linear correlations for AML (1-35 μg/mL) and IRB (2-35 μg/mL).
  • Validation according to International Conference on Harmonization guidelines demonstrated good performance.
  • The methods were successfully applied to determine AML and IRB in their marketed pharmaceutical formulations.

Conclusions:

  • The developed spectrophotometric methods are effective for the simultaneous assay of amlodipine besylate and irbesartan in pharmaceutical formulations.
  • These methods are suitable for routine quality control analysis in laboratories due to their simplicity and efficiency.
  • The proposed approaches are cost-effective, requiring no expensive solvents or complex instrumentation, making them ideal for time- and cost-sensitive routine testing.
Abstract

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