Development and Validation of A Stability-Indicating RP-HPLC Method For The Simultaneous Estimation of Eprosartan and Hydrochlorothiazide in Bulk and Pharmaceutical Dosage Forms

  • Unique Paper ID: 204695
  • Volume: 13
  • Issue: 1
  • PageNo: 3291-3295
  • Abstract:
  • A simple, precise, accurate, robust, and stability-indicating Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of Eprosartan and Hydrochlorothiazide in bulk drug substances and pharmaceutical dosage forms. Chromatographic separation was achieved using a C18 column under optimized chromatographic conditions employing a suitable mixture of phosphate buffer and organic solvent as mobile phase. The developed method was validated according to International Conference on Harmonisation (ICH) Q2(R1) guidelines with respect to specificity, linearity, precision, accuracy, robustness, limit of detection (LOD), and limit of quantification (LOQ). Both drugs exhibited excellent linearity within the selected concentration range with correlation coefficients greater than 0.999. Recovery studies demonstrated excellent accuracy with recoveries ranging from 98–102%. Precision studies showed %RSD values less than 2%, confirming the reproducibility of the method. Stress degradation studies were conducted under acidic, alkaline, oxidative, and photolytic conditions to establish the stability-indicating capability of the method. The developed method was found suitable for routine quality control analysis and stability assessment of Eprosartan and Hydrochlorothiazide combined dosage forms.

Copyright & License

Copyright © 2026 Authors retain the copyright of this article. This article is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

BibTeX

@article{204695,
        author = {Mirigam Sumanth},
        title = {Development and Validation of A Stability-Indicating RP-HPLC Method For The Simultaneous Estimation of Eprosartan and Hydrochlorothiazide in Bulk and Pharmaceutical Dosage Forms},
        journal = {International Journal of Innovative Research in Technology},
        year = {2026},
        volume = {13},
        number = {1},
        pages = {3291-3295},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=204695},
        abstract = {A simple, precise, accurate, robust, and stability-indicating Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of Eprosartan and Hydrochlorothiazide in bulk drug substances and pharmaceutical dosage forms. Chromatographic separation was achieved using a C18 column under optimized chromatographic conditions employing a suitable mixture of phosphate buffer and organic solvent as mobile phase. The developed method was validated according to International Conference on Harmonisation (ICH) Q2(R1) guidelines with respect to specificity, linearity, precision, accuracy, robustness, limit of detection (LOD), and limit of quantification (LOQ). Both drugs exhibited excellent linearity within the selected concentration range with correlation coefficients greater than 0.999. Recovery studies demonstrated excellent accuracy with recoveries ranging from 98–102%. Precision studies showed %RSD values less than 2%, confirming the reproducibility of the method. Stress degradation studies were conducted under acidic, alkaline, oxidative, and photolytic conditions to establish the stability-indicating capability of the method. The developed method was found suitable for routine quality control analysis and stability assessment of Eprosartan and Hydrochlorothiazide combined dosage forms.},
        keywords = {RP-HPLC, Eprosartan, Hydrochlorothiazide, Method Validation, Stability-Indicating Method, ICH Guidelines, Pharmaceutical Analysis.},
        month = {June},
        }

Cite This Article

Sumanth, M. (2026). Development and Validation of A Stability-Indicating RP-HPLC Method For The Simultaneous Estimation of Eprosartan and Hydrochlorothiazide in Bulk and Pharmaceutical Dosage Forms. International Journal of Innovative Research in Technology (IJIRT), 13(1), 3291–3295.

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