• image 01
    Volume 1, No.1, 2012
  • image 02
    Volume 1, No.2, 2012
  • image 01
    Volume 1, No.3, 2012
  • image 02
    Volume 2, No.1, 2013
  • image 02
    Volume 2, No.2, 2013
  • image 02
    Volume 2, No.S1, 2013
  • image 02
    Volume 2, No.3, 2013
  • image 02
    Volume 2, No.4, 2013
  • image 02
    Volume 3, No.1, 2014
  • image 02
    Volume 3, No.2, 2014
  • Volume 3, No3
    Volume 3, No.3, 2014
  • Volume 3, No4
    Volume 3, No.4, 2014
  • Volume 4, No1
    Volume 4, No.1, 2015
  • Volume 4, No2
    Volume 4, No.2, 2015
  • Volume 4, No3
    Volume 4, No.3, 2015
  • Volume 4, No4
    Volume 4, No.4, 2015
  • Volume 5, No1
    Volume 5, No.1, 2016
  • image 01
  • image 02
  • Login|Register
  • Chem Sci Trans., 2013, 2(4),  pp 1466-1474  

    DOI:10.7598/cst2013.582

    Research Article

    A Quantitative and Qualitative High Performance Liquid Chromatographic Determination of Aceclofenac Specified Impurity-B (Methyl[2-[(2, 6-dichlorophenyl)amino] phenyl]acetate) in Aceclofenac Bulk Drug

  • P L. SOMASHEKAR, P N. SANJAY PAI and GOPALKRISHNA RAO
  • Department of Quality Assurance, Al-Ameen College of Pharmacy, Near Lalbagh Main Gate, Hosur Road, Bangalore -560027, India
    Department of Pharmaceutical Chemistry, Goa College of Pharmacy, 18th June Road, Panaji, Goa- 403001, India
  • Abstract

    Aceclofenac is a phenylacetic acid derivative with potent analgesic and anti-inflammatory properties and an improved gastro-intestinal tolerance. In the present study, a reversed-phase HPLC method was developed for analysis of aceclofenac and applied for detection and quantification of aceclofenac specified impurity-B (methyl[2-[(2, 6-dichlorophenyl)amino]phenyl]acetate) with UV detection in bulk drug. Aceclofenac and its impurity were separated using an acetonitrile-phosphate buffer (60:40) isocratic method with a flow rate of 1 mL/min and UV detection at 275 nm. The retention times for aceclofenac and its impurity were 3.0 min and 13.04 min respectively. The method was validated as per ICH guidelines. The calibration was linear over the range of 1-25 mcg/mL for aceclofenac and 1-20 mcg/mL for Aceclofenac impurity-B. The method showed excellent sensitivity (detection limit of 10 μg/mL) with good precision and accuracy. This sensitive and selective method can be used for detection and quantification of aceclofenac impurity-B in aceclofenac bulk drug in order to control and regulate process related impurity.

    Keywords

    Aceclofenac, Aceclofenac impurity, HPLC method

    This article has been viwed 2259 times

      

    Citations for this article 0

      

    No Citations