Development and Validation of Stability Indicating RP-HPLC Method for Efonidipine Hydrochloride ethanolate

  • Unique Paper ID: 153288
  • Volume: 8
  • Issue: 6
  • PageNo: 340-345
  • Abstract:
  • The paper describes development and validation of a stability indicating chromatographic assay method for Efonidipine Hydrochloride ethanolate (EFD) in solid pharmaceutical dosage form. EFD and degradant products under varied stress conditions like hydrolysis at a range of pH, temperature, oxidation and exposure to light were analysed by developed RP-HPLC method with proper separation as well as good peak shape. The developed method consisted of mobile phase Methanol: water (50:50 v/v). The flow rate was 0.8 mL/min with a run time of 10 min and detection at 270 nm. The assay was performed on marketed formulation that showed 99.52% labelled claim. During the forced degradation studies, Efonidipine showed maximum degradation (10 %) under oxidative stress followed by 8 % photodegradation. The drug showed lower degradation under acid, base and thermal stress conditions, to the extent of 4 %, 3 % and 6 % respectively. It was also observed that the retention time of the degradant under photolytic and oxidative degradation were the same probably due to the formation of the same product.

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{153288,
        author = {Ms. Priyal Shah and Dr. Anuradha Gajjar},
        title = {Development and Validation of Stability Indicating RP-HPLC Method for Efonidipine Hydrochloride ethanolate},
        journal = {International Journal of Innovative Research in Technology},
        year = {},
        volume = {8},
        number = {6},
        pages = {340-345},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=153288},
        abstract = {The paper describes development and validation of a stability indicating chromatographic assay method for Efonidipine Hydrochloride ethanolate (EFD) in solid pharmaceutical dosage form. EFD and degradant products under varied stress conditions like hydrolysis at a range of pH, temperature, oxidation  and exposure to light were analysed by developed RP-HPLC method with proper separation as well as good peak shape. The developed method consisted of mobile phase Methanol: water (50:50 v/v). The flow rate was 0.8 mL/min with a run time of 10 min and detection at 270 nm. The assay was performed on marketed formulation that showed 99.52% labelled claim. During the forced degradation studies, Efonidipine showed maximum degradation (10 %) under oxidative stress followed by 8 % photodegradation. The drug showed lower degradation under acid, base and thermal stress conditions, to the extent of 4 %, 3 % and 6 % respectively. It was also observed that the retention time of the degradant under photolytic and oxidative degradation were the same probably due to the formation of the same product. },
        keywords = {Efonidipine hydrochloride ethanolate, Stability indicating assay method, stress conditions, anti-hypertensive, photodegradation.},
        month = {},
        }

Cite This Article

  • ISSN: 2349-6002
  • Volume: 8
  • Issue: 6
  • PageNo: 340-345

Development and Validation of Stability Indicating RP-HPLC Method for Efonidipine Hydrochloride ethanolate

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