Validated Stability-indicating HPTLC Method Development for Simultaneous Determination of Efonidipine hydrochloride and Metoprolol succinate as Bulk Drugs and in Combined Tablet Formulation

  • Unique Paper ID: 183177
  • Volume: 12
  • Issue: 3
  • PageNo: 421-425
  • Abstract:
  • A new simple, accurate and precise stability-indicating high performance thin layer chromatographic (HPTLC) analytical method has been developed and validated for the simultaneous quantitative analysis of Efonidipine hydrochloride and Metoprolol as bulk drugs and in combined tablet formulation. The objective of this study was to explore degradation behaviour of both drugs under ICH-recommended stress conditions, employing a newly designed stability indicating HPTLC method and validating it. The chromatographic separation was carried out using precoated silica gel 60F254 (10 × 10 cm) plates as stationary phase and mixture of Toluene: Ethyl Acetate: Methanol: Formic acid (5.5: 2.5: 2: 0.5, v/v/v/v) as mobile phase. The retention factors for metoprolol and efonidipine were 0.26 ± 0.05 and 0.72 ± 0.03, separately. The method that was optimized has been inspected for linearity, accuracy, precision, limit of detection, limit of quantification, and robustness according to ICH guidelines. Linear results were observed for both drugs in the concentration range of 800-2800 ng band-1 for Metoprolol and 500-1750 ng band-1 for Efonidipine. The % drug content after application of the method to commercial tablet formulation was found to be (Mean ± S.D.) 99.29 ±1.11 and 98.26 ±1.29 for Metoprolol and Efonidipine hydrochloride, respectively. These drugs in combined tablet dosage form can be quantified simultaneously with the developed method, as well as for routine analysis in quality control laboratories.

Copyright & License

Copyright © 2025 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{183177,
        author = {Padmanabh B. Deshpande and Nikita Bhadane and Ankit Rathod},
        title = {Validated Stability-indicating HPTLC Method Development for Simultaneous Determination of Efonidipine hydrochloride and Metoprolol succinate as Bulk Drugs and in Combined Tablet Formulation},
        journal = {International Journal of Innovative Research in Technology},
        year = {2025},
        volume = {12},
        number = {3},
        pages = {421-425},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=183177},
        abstract = {A new simple, accurate and precise stability-indicating high performance thin layer chromatographic (HPTLC) analytical method has been developed and validated for the simultaneous quantitative analysis of Efonidipine hydrochloride and Metoprolol as bulk drugs and in combined tablet formulation. The objective of this study was to explore degradation behaviour of both drugs under ICH-recommended stress conditions, employing a newly designed stability indicating HPTLC method and validating it. The chromatographic separation was carried out using precoated silica gel 60F254 (10 × 10 cm) plates as stationary phase and mixture of Toluene: Ethyl Acetate: Methanol: Formic acid (5.5: 2.5: 2: 0.5, v/v/v/v) as mobile phase. The retention factors for metoprolol and efonidipine were 0.26 ± 0.05 and 0.72 ± 0.03, separately. The method that was optimized has been inspected for linearity, accuracy, precision, limit of detection, limit of quantification, and robustness according to ICH guidelines. Linear results were observed for both drugs in the concentration range of 800-2800 ng band-1 for Metoprolol and 500-1750 ng band-1 for Efonidipine. The % drug content after application of the method to commercial tablet formulation was found to be (Mean ± S.D.) 99.29 ±1.11 and 98.26 ±1.29 for Metoprolol and Efonidipine hydrochloride, respectively. These drugs in combined tablet dosage form can be quantified simultaneously with the developed method, as well as for routine analysis in quality control laboratories.},
        keywords = {Efonidipine hydrochloride, Metoprolol, HPTLC, Stability Studies, Validation},
        month = {July},
        }

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