|
Development and Validation of Stability Indicating HPTLC Method for Estimation of Felodipine and Its Application to Degradation Kinetic Study of Felodipine in Alkaline Medium
|
|
| Author:
|
MS. VYAS, DR. DINESH SHAH, DR. SHAILESH SHAH, DR. GAJANAN KALYANKAR, MS. NEHALI VASHI
|
| Abstract:
|
An accurate, selective and precise stability indicating HPTLC method was developed and validated for the estimation
of felodipine in its pharmaceutical dosage form and extended its application to study degradation kinetic of felodipine
in alkaline medium.Chromatographic separation of drug was performed on pre-coated silica gel aluminium plate 60F254,
sample applicator used was semiautomaticCAMAG Linomat V. The selected mobile phase was toluene: ethyl acetate:
triethylamine (5:5:0.1 v/v/v)with UV detection at 245 nm.The retention factor (Rf) for felodipine was found to be
0.59.Results were found linear in the concentration range of 200-1000 ng/band. The method was validated as per ICH,
Q2R1 guidelines, demonstrating to be precise and accurate. This method was applied to estimate felodipine in
marketed formulation.Inherent stability of felodipine was studied by exposing drug substance to various stress
conditions namely acidic, alkaline and oxidative conditions. Relevant degradation was found to take place under these
conditions. Degradation kinetic of the felodipine was studied in 0.1, 0.55 and 1M NaOH at 60°C, 70°C and 80°C by
the developed method. Maximum degradation was observed in 1M NaOH at 80°C. Rate constant, half-life and shelf
life were calculated using the degradation rate equations.The results of stress testing reveal that the method is
stability indicating and specific. The proposed method is able to separate drug substance from degradation products
formed under the stress conditions. The developed method can be used for routine analysis of pharmaceutical
formulations in quality-control laboratories and for study of degradation kinetic of felodipine in pharmaceutical dosage
form.
|
| Keyword:
|
Felodipine, HPTLC, Stability indicating method, Alkaline degradation kinetics
|
| EOI:
|
-
|
| DOI:
|
https://doi.org/10.31838/ijpr/2019.11.02.091
|
| Download:
|
Request For Article
|
|
|