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  • Chem Sci Trans., 2014, 3(3),  pp 983-988  

    DOI:10.7598/cst2014.681

    Research Article

    Quantitative Determination of Acetic Acid in Gefitinib by Reverse Phase HPLC

  • AJAY SINGH RAWAT*, KAMLESH CHAUHAN, YOGENDRASINH PARMAR, POOJA SANNIGRAHI, DIVYESH PATEL, CHANDRAKANT BELWAL and ANAND VARDHAN
  • Sterling Biotech Limited, Jambusar State Highway, Village Masar 391421, Taluka, Padra, Distt: Vadodaram Gujarat, India
  • Abstract

    A improved, simple and economic reverse phase high performance liquid chromatography (RP-HPLC) method has been developed and validated as per ICH guidelines for the quantification of acetic acid present in Gefitinib as an solvent impurity. Validation studies demonstrated that the proposed RP-HPLC method is simple, specific, rapid, reliable and reproducible. The high recovery and low relative standard deviation confirm the suitability of the proposed method for the routine quality control analysis for the quantification of acetic acid in Gefitinib.

    Keywords

    Gefitinib; Acetic acid; High Performance Liquid Chromatography; Method Validation

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