Development and validation of HPLC method for simultaneous determination of rimantadine marketed product

Burcu Üner; Ahmet Doğan Ergin

Development and validation of HPLC method for simultaneous determination of rimantadine marketed product

Abstract

This study presents the development and validation of a novel high-performance liquid chromatography (HPLC) method for the quantification of rimantadine in pharmaceutical formulations. Rimantadine, an antiviral drug primarily used in the treatment of influenza A, necessitates effective analytical methods for quality control. Our HPLC method employs a reverse-phase column with a mobile phase comprising acetonitrile and 15mM phosphate buffer (pH 3.0) and acetonitrile in the ratio of 65:35 water, under isocratic elution conditions. The detection was carried out using UV spectrophotometry at a wavelength of 270 nm. Method validation was performed in accordance with ICH guidelines, assessing parameters such as specificity, linearity, accuracy, precision, limit of detection (LOD), and limit of quantification (LOQ). The method demonstrated excellent linearity (r² > 0.999) across a wide concentration range. The precision, expressed as relative standard deviation (RSD), was below 2%, confirming the method's repeatability and reproducibility. Accuracy, tested through recovery studies, ranged from 98% to 102%. The developed method was successfully applied to analyze rimantadine in commercially available rimantadine HCl formulations, with results indicating consistent drug content within the specified limits. This validated HPLC method offers a reliable, efficient, and cost-effective approach for routine quality control analysis of rimantadine in pharmaceutical products.

Keywords

References

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Details

Primary Language

English

Subjects

Pharmaceutical Delivery Technologies

Journal Section

Research Article

Authors

Burcu Üner
0000-0003-4691-0432
United States

Ahmet Doğan Ergin ^*
0000-0002-9387-0085
Türkiye

Publication Date

June 28, 2025

Submission Date

December 12, 2023

Acceptance Date

February 5, 2024

Published in Issue

Year 2024 Volume: 28 Number: 3

IZ

https://izlik.org/JA73FM36SW

Cite

RIS / Bibtex

APA

Üner, B., & Ergin, A. D. (2025). Development and validation of HPLC method for simultaneous determination of rimantadine marketed product. Journal of Research in Pharmacy, 28(3), 870-879. https://izlik.org/JA73FM36SW

AMA

1.Üner B, Ergin AD. Development and validation of HPLC method for simultaneous determination of rimantadine marketed product. J. Res. Pharm. 2025;28(3):870-879. https://izlik.org/JA73FM36SW

Chicago

Üner, Burcu, and Ahmet Doğan Ergin. 2025. “Development and Validation of HPLC Method for Simultaneous Determination of Rimantadine Marketed Product”. Journal of Research in Pharmacy 28 (3): 870-79. https://izlik.org/JA73FM36SW.

EndNote

Üner B, Ergin AD (June 1, 2025) Development and validation of HPLC method for simultaneous determination of rimantadine marketed product. Journal of Research in Pharmacy 28 3 870–879.

IEEE

[1]B. Üner and A. D. Ergin, “Development and validation of HPLC method for simultaneous determination of rimantadine marketed product”, J. Res. Pharm., vol. 28, no. 3, pp. 870–879, June 2025, [Online]. Available: https://izlik.org/JA73FM36SW

ISNAD

Üner, Burcu - Ergin, Ahmet Doğan. “Development and Validation of HPLC Method for Simultaneous Determination of Rimantadine Marketed Product”. Journal of Research in Pharmacy 28/3 (June 1, 2025): 870-879. https://izlik.org/JA73FM36SW.

JAMA

1.Üner B, Ergin AD. Development and validation of HPLC method for simultaneous determination of rimantadine marketed product. J. Res. Pharm. 2025;28:870–879.

MLA

Üner, Burcu, and Ahmet Doğan Ergin. “Development and Validation of HPLC Method for Simultaneous Determination of Rimantadine Marketed Product”. Journal of Research in Pharmacy, vol. 28, no. 3, June 2025, pp. 870-9, https://izlik.org/JA73FM36SW.

Vancouver

1.Burcu Üner, Ahmet Doğan Ergin. Development and validation of HPLC method for simultaneous determination of rimantadine marketed product. J. Res. Pharm. [Internet]. 2025 Jun. 1;28(3):870-9. Available from: https://izlik.org/JA73FM36SW