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ICH, “Validation of Analytical Procedures: Text and Metho-dology (Q2(R1)) International Conference on Harmonization,” IFPMA, Geneva, 2005.

has been cited by the following article:

• TITLE: Isolation and Characterization of S-Enantiomer in Montelukast

  AUTHORS: Vijaya Lakshmi Maddala, Kishore Kumar Kakumani, Kameswara Rao Chimalakonda, Srinivasulu Polisetty, P. C. Ray

  KEYWORDS: (S)-Isomer; Montelukast; Supercritical Fluid Chromatography (SFC)

  JOURNAL NAME: American Journal of Analytical Chemistry, Vol.4 No.1, January 22, 2013

  ABSTRACT: A simple and rapid Supercritical Fluid Chromatography (SFC) Method has been developed to isolate and characterize the S-Isomer of Montelukast by using normal phase Amylose based AS-H with 250 mm × 30 mm, 5 microns column using a mobile phase system containing super critical fluid carbon dioxide (CO2) and the percentage of 2-Propanol as a mobile phase (85:15) and detection at 230 nm. The isolated S-Isomer was characterized by using FT-IR, ESI-MS, HPLC and 1H NMR. The purity of isolated S-Isomer is about 98%.