Man, H.W., Schafer, P., Wong, L.M., Patterson, R.T., Corral, L.G., Raymon, H., Blease, K., Leisten, J., Shirley, M.A., Tang, Y., Babusis, D.M., Chen, R., Stirling, D. and Muller, G.W. (2009) Discovery of (S)-N-{2-[1-(3-Ethoxy-4-Methoxyphenyl)-2- Methanesulfonylethyl]-1,3-Dioxo-2,3-Dihydro-1H-Isoindol-4-yl}Acetamide (Apre- milast), a Potent and Orally Active Phosphodiesterase 4 and Tumor Necrosis Factor-α Inhibitor. Journal of Medicinal Chemistry, 52, 1522-1524.
https://doi.org/10.1021/jm900210d

has been cited by the following article:

• TITLE: Development and Validation of Stability Indicating Rapid RP-LC Method for Determination of Process and Degradation Related Impurities of Apremilast, an Anti-Inflammatory Drug

  AUTHORS: Shashikant B. Landge, Sunil B. Dahale, Sanjay A. Jadhav, Pavankumar V. Solanki, Saroj R. Bembalkar, Vijayavitthal T. Mathad

  KEYWORDS: Apremilast, Stability Indicating, RP-LC, PDE4 Inhibitor, Forced Degradation

  JOURNAL NAME: American Journal of Analytical Chemistry, Vol.8 No.6, June 15, 2017

  ABSTRACT: A new, specific, rapid and stability indicating reversed phase liquid chro-matographic (RP-LC) method for the determination of process related and degradation related impurities of Apremilast has been developed and validated. The degradation study performed in acid, base, oxidative, photolytic, and thermal stressed conditions. Eight process related impurities (Imp-1 to Imp-8) in test sample of Apremilast have been detected by developed RP-LC method. The good chromatographic resolution between the peaks of process related impurities, degradation impurities and Apremilast has been achieved on a Synergi Max-RP 80 A (150 × 4.6 mm ID), 4 μ column. The process and degradation related impurities were characterized by mass spectrometry, 1H NMR and FT-IR spectral data. The method was validated as per ICH guideline and found to be specific, rapid, and stability indicating. The proposed RP-PLC method was successfully applied to the analysis of drug substance samples of Apremilast.