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

Year 2024, Volume: 28 Issue: 3, 870 - 879, 28.06.2025

Burcu Üner , Ahmet Doğan Ergin

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

Rimantadine HPLC Quantitative Validation Antiviral

References

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There are 27 citations in total.

Details

Primary Language English
Subjects Pharmaceutical Delivery Technologies
Journal Section Articles
Authors

Burcu Üner 0000-0003-4691-0432

Ahmet Doğan Ergin 0000-0002-9387-0085

Publication Date June 28, 2025
Submission Date December 12, 2023
Acceptance Date February 5, 2024
Published in Issue Year 2024 Volume: 28 Issue: 3

Cite

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.
AMA Üner B, Ergin AD. Development and validation of HPLC method for simultaneous determination of rimantadine marketed product. J. Res. Pharm. June 2025;28(3):870-879.
Chicago Üner, Burcu, and Ahmet Doğan Ergin. “Development and Validation of HPLC Method for Simultaneous Determination of Rimantadine Marketed Product”. Journal of Research in Pharmacy 28, no. 3 (June 2025): 870-79.
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 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, 2025.
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 2025), 870-879.
JAMA 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, 2025, pp. 870-9.
Vancouver Üner B, Ergin AD. Development and validation of HPLC method for simultaneous determination of rimantadine marketed product. J. Res. Pharm. 2025;28(3):870-9.