Analytical Method Development and Validation for Estimation of Cardio Protective Agents in Formulated Dosage Form By RP-HPLC Method

  • Unique Paper ID: 204697
  • Volume: 13
  • Issue: 1
  • PageNo: 3230-3233
  • Abstract:
  • A simple, precise, accurate, and stability-indicating Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of Indapamide and Nebivolol Hydrochloride in bulk drugs and pharmaceutical dosage forms. Method development was carried out using a Waters X-Bridge BEH C18 column (150 × 4.6 mm, 3.5 µm). Various chromatographic conditions were investigated to obtain satisfactory peak resolution, theoretical plate count, and tailing factor. The optimized chromatographic conditions consisted of Methanol: Phosphate Buffer (70:30 v/v, pH 4 adjusted with orthophosphoric acid) as mobile phase, flow rate of 0.5 mL/min, detection wavelength of 239 nm, and injection volume of 20 µL. Under optimized conditions, Indapamide and Nebivolol Hydrochloride were eluted at retention times of 3.278 min and 6.404 min respectively. The method was validated according to ICH Q2(R1) guidelines with respect to specificity, linearity, accuracy, precision, robustness, LOD, and LOQ. The developed method demonstrated excellent analytical performance and was found suitable for routine quality control analysis of combined tablet 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{204697,
        author = {K Nandini},
        title = {Analytical Method Development and Validation for Estimation of Cardio Protective Agents in Formulated Dosage Form By RP-HPLC Method},
        journal = {International Journal of Innovative Research in Technology},
        year = {2026},
        volume = {13},
        number = {1},
        pages = {3230-3233},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=204697},
        abstract = {A simple, precise, accurate, and stability-indicating Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of Indapamide and Nebivolol Hydrochloride in bulk drugs and pharmaceutical dosage forms. Method development was carried out using a Waters X-Bridge BEH C18 column (150 × 4.6 mm, 3.5 µm). Various chromatographic conditions were investigated to obtain satisfactory peak resolution, theoretical plate count, and tailing factor. The optimized chromatographic conditions consisted of Methanol: Phosphate Buffer (70:30 v/v, pH 4 adjusted with orthophosphoric acid) as mobile phase, flow rate of 0.5 mL/min, detection wavelength of 239 nm, and injection volume of 20 µL. Under optimized conditions, Indapamide and Nebivolol Hydrochloride were eluted at retention times of 3.278 min and 6.404 min respectively. The method was validated according to ICH Q2(R1) guidelines with respect to specificity, linearity, accuracy, precision, robustness, LOD, and LOQ. The developed method demonstrated excellent analytical performance and was found suitable for routine quality control analysis of combined tablet dosage forms.},
        keywords = {RP-HPLC, Indapamide, Nebivolol Hydrochloride, Method Validation, Stability-Indicating Method, ICH Guidelines, Pharmaceutical Analysis.},
        month = {June},
        }

Cite This Article

Nandini, K. (2026). Analytical Method Development and Validation for Estimation of Cardio Protective Agents in Formulated Dosage Form By RP-HPLC Method. International Journal of Innovative Research in Technology (IJIRT), 13(1), 3230–3233.

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