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  • Chem Sci Trans., 2014, 3(3),  pp 929-936  

    DOI:10.7598/cst2014.798

    Research Article

    Quantification of Genotoxic Impurity 2-Butyl p-toluene- sulfonate at ppm Level by LC-MS/MS in Naproxen Drug Substance

  • M. B. V. NARAYANA1*, K. B.CHANDRASEKHAR2 and B. M. RAO3
  • 11Analytical Research, Matrix Laboratories Limited, Hyderabad-500 072, India
    22Department of Chemistry, Jawaharlal Nehru Technological University College of Engineering, Anantapur-515002, India
    33Analytical Research, Johnson and Johnson Ltd., Mumbai-400080, India
  • Abstract

    The objective of the present research work is to develop a suitable LC-MS/MS method for the quantitative determination of genotoxic alkylating impurity 2-butyl p-toluenesulfonate present in naproxen drug substance at ppm level. The LC-MS/MS method was developed on Xterra MS C18 50 mm column using the mobile phase consists a mixture of 10 mM ammonium acetate and acetonirile using a isocratic composition of 20:80 v/v. Ion source is electrospray ionization (ESI) positive mode, source temperature is 300 oC, gas flow is 10 L/min, Nebuliser pressure is 50 psi, capillary voltage is 4000 V. Under these LC and MS conditions 2-butyl p-toluenesulfonate was quantified by selected ion mode (SIM) of 173. The limit of detection and the limit of quantitation for the impurity were established. This method has been tested in a number of naproxen samples and used successfully for quantification of the genotoxic impurity at ppm level. Validation of the developed LC-MS/MS method was carried out as per ICH requirements and the data shows that the proposed method is specific, linear, accurate, precise and robust. The developed LC-MS/MS method was found to be suitable to quantify the genotoxic impurity at ppm level present in naproxen drug substance.

    Keywords

    Genotoxic impurity, Alkylating agent, LCMS, Electro spray ionization, Atmospheric chemical ionization

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