A Comprehensive Review of Analytical Method – Development and Method Validation of Digoxin Tablets

Year : 2025 | Volume : 12 | Issue : 01 | Page : 47 58
    By

    Kanmani M,

  • Sankar P,

  • Anbazhagan S,

  1. Student, Department of Pharmacy, Surya School of Pharmacy, Villupuram, Tamil Nadu, India
  2. Associate Professor, Department of Pharmaceutical Chemistry, Surya School of Pharmacy, Villupuram, Tamil Nadu, India
  3. Principal, Department of Chemistry, Surya School of Pharmacy, Villupuram, Tamil Nadu, India

Abstract

The main objective of this review is to give an outline of the method development and validation process of digoxin, and this review covers the different types of spectroscopic and chromatographic techniques, such as HPLC, UHPLC-Tandem mass spectroscopy, TLC, and LC-MS. A novel method for the determination of digoxin in biological samples has been developed and validated, focusing on improving sensitivity, specificity, and reproducibility. The method was validated in terms of linearity, accuracy, precision, specificity, detection limit, quantification limit, and stability according to the guidelines of the international conference on harmonization (ICH). The precision and accuracy of the method met the required standards for clinical applications, demonstrating minimal intra and inter day variation digoxin a cardiac glycoside used in the treatment heart failure and arrhythmias, requires precise quantification due to its narrow therapeutic index, high performance liquid chromatography coupled with ultraviolet detection, optimized for the separation and quantification of digoxin in plasma, the method development process involved selecting an relevant mobile phase composition, stationary phase and ensuring the chromatographic condition, such as flow rate and temperature, the linearity limit of detection(LOD), limit of quantification, precision, and accurately assessed the method development provide reliable, systematic and applicable for clinical and pharmacokinetic studies of digoxin.

Keywords: LC-MS, limit of detection, digoxin, pharmacokinetic studies, ICH, method validation, thin layer chromatography, analytical method.

[This article belongs to Research & Reviews: A Journal of Drug Formulation, Development and Production ]

How to cite this article:
Kanmani M, Sankar P, Anbazhagan S. A Comprehensive Review of Analytical Method – Development and Method Validation of Digoxin Tablets. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2025; 12(01):47-58.
How to cite this URL:
Kanmani M, Sankar P, Anbazhagan S. A Comprehensive Review of Analytical Method – Development and Method Validation of Digoxin Tablets. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2025; 12(01):47-58. Available from: https://journals.stmjournals.com/rrjodfdp/article=2025/view=204244


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Regular Issue Subscription Review Article
Volume 12
Issue 01
Received 22/01/2025
Accepted 19/02/2025
Published 20/03/2025
Publication Time 57 Days
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