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Thomas, S., Paul, S.K., Shandilya, S., Agarwal, A., Saxena, N., Awasthi, A.K., Matta, H., Vir, D. and Mathel, C.S. (2012) Identification and Structural Elucidation of Two Process Impurities and Stress Degradants in Darifenacin Hydrobromide Active Pharmaceutical Ingredient by LC-ESI/MSn. Analyst, 137, 3571-3582.
http://dx.doi.org/10.1039/c2an35454c

has been cited by the following article:

• 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.