View More View Less
  • 1 Andhra University Department of Pharmaceutical Sciences Visakhapatnam 530003 India
  • 2 Indian Institute of Chemical Technology Analytical Chemistry Division Tarnaka, Hyderabad 500007 India
Restricted access

A new quantitative densitometric HPTLC method has been developed for analysis and determination of the stability of anastrozole, both in the bulk material and in formulations. The method employed silica gel thin-layer chromatography (TLC) plates with fluorescent indicator, instrumental band-wise application of samples and standards, development with toluene-acetone-ammonia 6:4:0.3 ( v/v ) as mobile phase, and UV absorption/reflectance scanning with densitometric detection at 200 nm. The applicability of the method has been evaluated by analyzing a non-steroidal anti cancer tablet formulation containing anastrozole in specified amounts (as per label claim). Linearity, accuracy, precision, limit of detection, and limit of quantification were validated. Recovery of anastrozole from 1-mg tablet formulations ranged from 98.9 to 101.5%. Intraday and inter-day precision were 1.34% and 1.59% respectively. The limits of detection and quantification were 70.52 and 213.68 ng per band. The correlation coefficient for the anastrozole calibration plot was 0.9983 ± 0.0016 over the range of 500–1500 ng with regard to peak area. Stability-indicating studies suggested the drug does not undergo degradation under acidic or oxidizing conditions but alkaline conditions facilitated degradation, as was evident from the additional peaks observed. As the method could effectively separate the drug from its degradation products, it can be used as a stability indicating method and is thus suitable for routine quality-control analysis.

  • L. Balducci , Crit. Rev. Oncol. Hematol. 46 (2003) 211–220.

    Balducci L. , '' (2003 ) 46 Crit. Rev. Oncol. Hematol. : 211 -220.

  • J. Geisler, P.E. Lomning , Clin. Cancer Res. 11 (2005) 2809–2821.

    Lomning P.E. , '' (2005 ) 11 Clin. Cancer Res. : 2809 -2821.

  • J.M. Nabholtz , Oncology 70 (2006) 1–12.

    Nabholtz J.M. , '' (2006 ) 70 Oncology : 1 -12.

  • L. Perey, R. Paridaens, H. Hawle, K. Zaman, F. Nole, H. Wildiers, M. Fiche, D. Dietrich, P. Clement, D. Koberle, A. Goldhirsch, B. Thurlimann , Ann. Oncol. 18 (2007) 64–69.

    Thurlimann B. , '' (2007 ) 18 Ann. Oncol. : 64 -69.

  • F. Janicke , Breast 13 (2004) 10–18.

    Janicke F. , '' (2004 ) 13 Breast : 10 -18.

  • P.E. Lomning , BMJ 20 (2001) 880–881.

    Lomning P.E. , '' (2001 ) 20 BMJ : 880 -881.

  • G.D. Mendes, D. Hamamoto, J. Ilha, A.D.S. Pereira, G.D. Nucci , J. Chromatogr. B 850 (2007) 553–559.

    Nucci G.D. , '' (2007 ) 850 J. Chromatogr. B : 553 -559.

  • C.S. Zhao, S.M. Cui, R.G. Jang, Z.G. He, R.H. Zhang , Chin. Pharm. J. 38 (2003) 135–137.

    Zhang R.H. , '' (2003 ) 38 Chin. Pharm. J. : 135 -137.

  • J.R. Flores, J.J.B. Nevado, G.C. Penalvo, M.L.R. Caceres , Chromatographia 56 (2002) 283–288.

    Caceres M.L.R. , '' (2002 ) 56 Chromatographia : 283 -288.

  • J.J. Berzas, J. Rodríguez, A.M. Contento, M.P. Cabello , J. Sep. Sci. 26 (2003) 908–914.

    Cabello M.P. , '' (2003 ) 26 J. Sep. Sci. : 908 -914.

  • G. Duan, J. Lian, M. Zuo , Biomed. Chrom. 16 (2002) 400–403.

    Zuo M. , '' (2002 ) 16 Biomed. Chrom. : 400 -403.

  • G. Saravana, M.V. Suryanarayana, M.J. Jadhav, M. Ravi Kumar, N. Someswarrao, P.V.R. Acharyulu , Chromatographia 66 (2007) 431–434.

    Acharyulu P.V.R. , '' (2007 ) 66 Chromatographia : 431 -434.

  • U. Mareck, H. Geyer, S. Guddat, N. Haenett, A. Kuch, M. Kohler, G. Opfermann, M. Thevis, W. Schanzer , Rapid Commun. Mass Spectrom. 20 (2006) 1954–1962.

    Schanzer W. , '' (2006 ) 20 Rapid Commun. Mass Spectrom. : 1954 -1962.

  • S.G. Hiriyanna, K. Basavaiah , J. Braz. Chem. Soc. 19 (2008) 397–404.

    Basavaiah K. , '' (2008 ) 19 J. Braz. Chem. Soc. : 397 -404.

  • ICH, Text on Validation of Analytical Procedures — ICH Harmonised Tripartite Guideline, Geneva, 1994.

  • ICH, Validation of Analytical Procedures: Methodology — ICH Harmonised Tripartite Guideline, Geneva, 1996.

Monthly Content Usage

Abstract Views Full Text Views PDF Downloads
Jun 2020 0 0 0
Jul 2020 1 0 0
Aug 2020 1 0 0
Sep 2020 1 0 0
Oct 2020 0 0 0
Nov 2020 2 0 0
Dec 2020 0 0 0