• 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., 2012, 1(2),  pp 415-423  

    DOI:10.7598/cst2012.156

    Research Article

    Simple and Reliable Gas Chromatography Method for the Determination of 3-Quinuclidinol Content in Solifenacin Succinate Drug Substance

  • M. NARENDRA KUMARa*, V. KRISHNA REDDYb, HEMANT KUMAR SHARMAa, P. MADHAVA REDDYa, K.V.S.N. RAJUa, PRADEEP RAJPUTa and T. KALEEMULLAHa
  • aAurobindo Pharma Limited Research Centre-II, Survey No:71&72, Indrakaran Village, Sangareddy Mandal, Medak - 502 329, Andhra Pradesh, India
    bDepartment of Chemistry, Sri Krishnadevaraya University, Anantapur - 515 003, Andhra Pradesh, India
  • Abstract

    A simple and reliable gas chromatography method has been developed and validated for the determination of 3-quinuclidinol content in solifenacin succinate drug substance, using dimethyl-sulfoxide (DMSO) as internal standard (IS). Efficient chromatographic separation was achieved on DB-Wax, 15 m long with 0.53 mm i.d., 1.0 m particle diameter column consists with 100% polyethylene glycol as stationary phase including carrier gas as Helium. The analyte and internal standard were extracted in chloroform and monitored by flame ionization detector. The performance of the method was assessed by evaluating specificity, precision (repeatability, reproducibility), linearity, robustness and accuracy. No interference of organic solvents used in the synthesis was observed. The proposed method has a potential application to drug substances which may contains 3-quinuclidinol. The limits of detection (LOD) and limits of quantification (LOQ) established for 3-quinuclidinol, 40 g g-1 and 120 g g-1 respectively. The correlation coefficient value of linearity experiment is 0.9997. The average recovery for 3-quinuclidinol is 100.8%. The results proves that the validated method was suitable for determining 3-quinuclidinol content and method can be successfully applied for the routine analysis of solifenacin succinate drug substance.

    Keywords

    Gas chromatography, Solifenacin succinate, 3-Quinuclidinol, Extraction, Validation

    This article has been viwed 2945 times

      

    Citations for this article 1

      

    Download Citations