Year : 2025 | Volume : 12 | Issue : 01 | Page : 59 71

Suganthi K,

Shankar P,

Anbazhagan S,

Student, Department of Pharmacy, Surya School of pharmacy Villupuram, Tamil Nadu, India
Associate Professor, Department of pharmaceutical chemistry, Surya School of pharmacy Villupuram, Tamil Nadu, India
Principal, Department of chemistry, Surya School of pharmacy Villupuram, Tamil Nadu, India

Abstract

The review provides an in-depth analysis of the analytical method development and validation process for amiodarone tablets. Method validation is crucial in the pharmaceutical industry for ensuring the quality and efficacy of tablets, as it ensures the accuracy, precision, and reliability of analytical techniques used in drug testing. It is a prerequisite for method development, adhering to good manufacturing practices, and optimizing processes. This review aims to consolidate and analyse diverse studies on reliable and efficient analytical methodologies, considering factors like speed, specificity, sensitivity, selectivity, accuracy, precision, cost, convenience, instrument availability, technical expertise, and sample analysis numbers. The development of analytical methods and instruments has significantly reduced analysis time, increased precision , and reduced costs, leading to significant investment in advanced analytical laboratories by pharmaceutical organizations. These techniques are utilized in active pharmaceutical ingredients, excipients, drug products, degradation products, and residual solvent.

Keywords: Amiodarone, analytical method development, drug development, method validation, pharmaceutical analysis.

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

How to cite this article:
Suganthi K, Shankar P, Anbazhagan S. A Review of Analytical Method Development and Validation of Amiodarone Pharmaceutical Dosage Form. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2025; 12(01):59-71.

How to cite this URL:
Suganthi K, Shankar P, Anbazhagan S. A Review of Analytical Method Development and Validation of Amiodarone Pharmaceutical Dosage Form. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2025; 12(01):59-71. Available from: https://journals.stmjournals.com/rrjodfdp/article=2025/view=203913

References

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7. Patil Divyashree Kantilal, Amit Kumar R Dhankani, Mansi A Dhankani, S.P. Pawar. Advancements in Method Development and Validation for Levocetirizine: A Comprehensive Review. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2024; 11(01):15-27.

8. Amit Gosar, Deepesh Patil, Advait Avalaskar, Narendra Aarkashi, Samadhan Aware. Development and Validation of New Rp-Hplc Method for Analysis of Amiodarone Hydrochloride and its Related Compounds. World Journal Pharmaceutical Research.2018; 7(18):755-773, DOI: 10.20959/wjpr201818-13457.

9. S. S. Patil, Y. H. Shaikh, C. V. Panchal, S. J. Wakode, B. N. Poul. Method Development and Validation of Amiodarone in Bulk and Pharmaceutical Dosage Form by RP-HPLC. International Journal of Pharmacy and Analaytical Research.2015;4(3):365-380.

10. Vemugunta Ramakrishna, Baratam Anupama, Chukkapalli Manisha. Development and Validation of Stability Indicating Rp-Hplc Method for the Estimation of Amiodarone in Bulk and Pharmaceutical Dosage Forms.PHARMANEST An International Journal of Advances in Pharmaceutical Sciences.2015; 6(2):2743-2749.

11. Noor SW, Dr. Shailesh WJ, Noor SS, Fakir JS, Vijay G. Rokade. Development and Validation of Stability Indicating Assay for the Estimation of Amiodarone in Tablet Dosage Form by UV Spectrophotometric Method. World Journal of Pharmacy and Pharmaceutical Sciences. 2020; 9(6):1207-1219, DOI: 10.20959/wjpps20206-16252.

12. Andrew Joseph D’Souza, R. S. Lokhande, Tushar Anvekar. Development and Validation of Gas Chromatography Method for the Detection of Residual Ethanol, Isopropyl Alcohol and Toluene in Amiodarone Hydrochloride Drug Substance. International Journal of Pharmaceutical Sciences and Research. 2019; 10(11): 5057-5062.

13. Ramanlal N. Kachave, Komal P. Jadhav. Analytical Method Development and Validation: A Review .International Journal of Creative Research Thoughts (IJCRT).2021; 9(8):b554- b570.

Regular Issue Subscription Review Article

Research & Reviews: A Journal of Drug Formulation, Development and Production

ISSN: 2394-1944

Volume	12
Issue	01
Received	13/01/2025
Accepted	04/03/2025
Published	19/03/2025
Publication Time	65 Days

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