Development and Validation of Stability Indicating RP-HPLC Method for Efonidipine Hydrochloride ethanolate
Author(s):
Ms. Priyal Shah, Dr. Anuradha Gajjar
Keywords:
Efonidipine hydrochloride ethanolate, Stability indicating assay method, stress conditions, anti-hypertensive, photodegradation.
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.
Article Details
Unique Paper ID: 153288

Publication Volume & Issue: Volume 8, Issue 6

Page(s): 340 - 345
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