Novel stability indicating HPLC method for determination of Terbinafine tablet for the treatment of Anti-fungal infection

  • Unique Paper ID: 184608
  • Volume: 12
  • Issue: 4
  • PageNo: 2069-2077
  • Abstract:
  • Terbinafine Hydrochloride (TH) is a new potent antifungal agent. Several HPTLC, non-aqueous voltametric, spectrometric methods, ion-pair RP chromatography and Stability-indicating HPTLC methods have been published till now. The aim of the present study is to develop and validate simple, precise, specific and sensitive stability indicating reversed-phase HPLC (RP-HPLC) method for analysis of Terbinafine Hydrochloride in bulk and in tablet dosage form. Based on the TBH peak limit, initially there was no fixed and steady retention time and consequently in order to maintain the column saturated with high concentration of TBH (1 mg/ml) solution, the column was initially run with the solution at the start of a batch and also at every specified time in the series to determine the stillness of the column. TBH was subjected to acidic, basic and neutral (with water) hydrolysis, oxidative, thermal and photodegradation and it was found that drug was degraded in acidic and photolytic condition. Statistical analysis proved that the developed method was accurate, precise, reproducible, specific and sensitive and can be used for routine analysis. Results also indicate that HPLC method employed in the study can detect any degradation of the product and any degradation impurities formed thereby making it a proper stability indicating method.

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{184608,
        author = {Sharma Harsh and Sharma Ramakant and Vengurlekar Sudha},
        title = {Novel stability indicating HPLC method for determination of Terbinafine tablet for the treatment of Anti-fungal infection},
        journal = {International Journal of Innovative Research in Technology},
        year = {2025},
        volume = {12},
        number = {4},
        pages = {2069-2077},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=184608},
        abstract = {Terbinafine Hydrochloride (TH) is a new potent antifungal agent. Several HPTLC, non-aqueous voltametric, spectrometric methods, ion-pair RP chromatography and Stability-indicating HPTLC methods have been published till now. The aim of the present study is to develop and validate simple, precise, specific and sensitive stability indicating reversed-phase HPLC (RP-HPLC) method for analysis of Terbinafine Hydrochloride in bulk and in tablet dosage form. Based on the TBH peak limit, initially there was no fixed and steady retention time and consequently in order to maintain the column saturated with high concentration of TBH (1 mg/ml) solution, the column was initially run with the solution at the start of a batch and also at every specified time in the series to determine the stillness of the column.  TBH was subjected to acidic, basic and neutral (with water) hydrolysis, oxidative, thermal and photodegradation and it was found that drug was degraded in acidic and photolytic condition. Statistical analysis proved that the developed method was accurate, precise, reproducible, specific and sensitive and can be used for routine analysis. Results also indicate that HPLC method employed in the study can detect any degradation of the product and any degradation impurities formed thereby making it a proper stability indicating method.},
        keywords = {Terbinafine hydrochloride, reproducible, degradation, stability indicating method.},
        month = {September},
        }

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