TITLE:
Development and Validation of a Stability-Indicating RP-HPLC Method for Determination of Darifenacin Hydrobromide in Bulk Drugs
AUTHORS:
Mohammed Nazeerunnisa, Lakshmi Garikapati, Syama Sundar Bethanabhatla
KEYWORDS:
Darifenacin Hydrobromide, Stability-Indicating, Degradation, Validation, RP-HPLC
JOURNAL NAME:
American Journal of Analytical Chemistry,
Vol.5 No.17,
December
18,
2014
ABSTRACT: An isocratic stability-indicating
reversed phase high performance liquid chromatographic method (RP-HPLC) was
developed for determination of process related impurities and assay of darifenacin
hydrobromide (DRF) in bulk drugs. DRF was subjected to various stress
conditions such as hydrolysis (acid, base, and neutral), oxidation, photolysis
and thermal degradation as per International Conference on Harmonization (ICH
Q1A(R2) and Q1B) prescribed conditions to investigate the stability-indicating
ability of the method. Significant degradation was observed during acidic
hydrolysis and oxidative stress conditions. The chromatographic separation was
accomplished on a Prodigy C8 column (250 × 4.6 mm, 5 μm) with mobile phase consisting of 0.05 M
ammonium acetate (pH adjusted to 7.2 by using ammonia solution) and methanol
(36% acetonitrile) in 35:65 v/v ratio in an isocratic elution mode at a flow
rate of 1.0 mL/min at 25°C. Detection of analytes
was carried out using photo diode array detector at a wavelength of 215 nm. The
developed LC method was validated with respect to accuracy, linearity, precision,
limits of detection and quantitation and robustness as per ICH guidelines.