Novel Analytical Techniques for the Development and Validation of Azilsartan Medoxomil

Venugopal Ramamurthy
Department of Pharmaceutical Chemistry, Sri Bhavani College of Pharmacy, Kandappankurichi, Cuddalore, India

Abstract

The present study was undertaken to develop and validate novel analytical techniques for the quantitative estimation and quality evaluation of Azilsartan Medoxomil, an angiotensin II receptor blocker used in the management of hypertension. Analytical methods based on UV-visible spectrophotometry, ATR-FTIR spectroscopy, and reverse-phase high-performance liquid chromatography (RP-HPLC) were developed and evaluated for their suitability, specificity, accuracy, precision, sensitivity, ruggedness, robustness, and stability-indicating capability. Overall, the developed analytical techniques were found to be simple, sensitive, accurate, precise, robust, and reliable for the identification and quantitative determination of Azilsartan Medoxomil and may be suitably applied for routine pharmaceutical quality-control analysis.

Keywords

Azilsartan Medoxomil; UV-Visible Spectrophotometry; ATR-FTIR; RP-HPLC; Method Development; Method Validation; Accuracy; Precision; Robustness; Forced Degradation; Stability-Indicating Method

Citation

Venugopal Ramamurthy. 2026 “Novel Analytical Techniques for the Development and Validation of Azilsartan Medoxomil” International Journal of Current Science Research (IJCSR) e-ISSN: 2454-5422: 12(9): 1-14.

References

  1. Masthanamma SK, Pradeepthi, Jahnavi. Stability indicating RP-HPLC method for determination of azilsartan medoxomil in pharmaceutical dosage form. Res J Pharm Technol. 2014; 7(2): 168-172.
  2. Srinivasan R, Kamal Chandra J, Rajesh Kumar D, Dushyanth Kumar N. Stability indicating RP-HPLC method for determination of azilsartan medoxomil in bulk and its dosage form. Int J Pharm Anal Res. 2014; 3(4): 445-452.
  3. Kuze Y, Kogame A, Jinno F, Kondo T, Asahi S. Development, validation and application of the liquid chromatography tandem mass spectrometry method for simultaneous quantification of azilsartan medoxomil, azilsartan, and its 2 metabolites in human plasma. J Chromatogr B Analyt Technol Biomed Life Sci. 2015; 1001: 174-181.
  4. Gad MA, Amer SM, Zaazaa HE, Hassan SA. Strategies for stabilizing formulation and QbD assisted development of robust stability indicating method of azilsartan medoxomil/chlorthalidone. J Pharm Biomed Anal. 2020; 178: 112910.
  5. Nikam SR. Bioanalytical method development and validation of azilsartan medoxomil potassium in human plasma by reversed-phase high-performance liquid chromatography with solid-phase extraction and its application in bioequivalence study. Innov J Med Sci. 2021; 5(2).
  6. Zambre D, Hussain U, Sheikh S, Jaiswal S, Belgamwar V. Stability-indicating HPLC analysis of azilsartan medoxomil potassium: a QbD-based method development and validation. J Chromatogr B. 2025; 1259: 124599.
  7. Kher M, Bhatt V, Jani A, Sheth N. Development and validation of stability indicating chromatographic methods for determination of azilsartan medoxomil in pharmaceutical formulation: RP-HPLC and HPTLC approaches. Anal Chem Lett. 2020; 10(3).
  8. Mantena BPV, Rao SV, Appa Rao KMCh, Ramakrishna K, Srikanth Reddy R. Method development and validation for the determination of potential impurities present in azilsartan medoxomil tablets by reverse phase-ultra performance liquid chromatography. Anal Chem Lett. 2014; 4(5-6): 287-301.
  9. Chemometric and design of experiments-based analytical quality by design and green chemistry approaches to multipurpose high-pressure liquid chromatographic method for synchronous estimation of multiple fixed-dose combinations of azilsartan medoxomil. J AOAC Int. 2023; 106(1): 250-262.

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License: Creative Commons Attribution 4.0 International (CC BY 4.0)