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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.
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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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