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A validated stability indicating RP-HPLC method for valganciclovir, identification and characterization of forced degradation products of valganciclovir using LC-MS/MS

Autorzy
Identyfikatory
Warianty tytułu
Języki publikacji
EN
Abstrakty
EN
The objective of the present study was to report the stability of novel antiviral drug, valganciclovir based on the information obtained from forced degradation studies. Valganciclovir was subjected to forced hydrolytic (acidic, alkaline and neutral), oxidative, photolytic and thermal stress in accordance with the ICH guideline Q1A (R2). The drug showed labiality under only acidic and photoacidic conditions while it was stable to other stress conditions. Resolution of the drug and degradation products was achieved on a Hypersil Gold C-18 column (4.6 × 250 mm, 5 μm) utilizing acetonitrile (A) and potassium dihydrogen ortho phosphate buffer (pH 5.0; 0.01M) in the ratio of 5:95 (v/v) at a flow rate of 0.6 ml/min and at the detection wavelength 252 nm. The major acidic stress degradation product was characterized by LC-MS/MS and its fragmentation pathway was proposed. Validation of the LC-DAD method was carried out in accordance with ICH guideline. The method met all required criteria and was applied for analysis of commercially available tablets.
Rocznik
Strony
29--42
Opis fizyczny
Bibliogr. 17 poz., rys., tab.
Twórcy
autor
  • Sinhgad Technical Education Society’s Smt. Kashibai Navale College of Pharmacy, Kondhwa (Bk.) Pune 411 048 Maharashtra India
autor
  • PDEA’s Seth Govind Raghunath Sable College of Pharmacy Saswad, Tal-Purandar, Dist-Pune 412301 Maharashtra India
Bibliografia
  • [1] International Conference on Harmonization (ICH), Q1A (R2): Stability testing of new drug substances and products, IFPMA, Geneva, 2003
  • [2] World Health Organization (WHO): Draft stability testing of active pharmaceutical ingredients and pharmaceutical products, Geneva, 2007
  • [3] Committee for Proprietary Medicinal Products (CPMP): Note for guidance on stability testing: stability testing of existing active substances and related finished products, EMEA, London, 2002
  • [4] Therapeutic Products Directorate (TPD): Guidance for industry stability testing of existing drug substances and products, Health Canada, Ottawa, ON, 2003
  • [5] M. Bakshi and S. Singh, J. Pharm. Biomed. Anal., 28, 1011 (2002)
  • [6] Y. Wu, Biomed. Chromatogr., 14, 384 (2000)
  • [7] D.F. Martin, J. Sierra-Madero, and S. Walmsley, N. Engl. J. Med., 346, 1119 (2002)
  • [8] C. Paya, A. Humar, and E. Dominguez, Am. J. Transplant., 4, 611 (2004)
  • [9] H. Maag, Prodrugs: Challenges, and Rewards Part 1. Biotechnology: Pharmaceutical Aspects, Springer, New York, 2007
  • [10] B.Z. Awen, V. Dasari, B.R. Chandu, M. Khagga, and P. Katakam, IJPSR., 2, 55 (2011)
  • [11] B. Topal, B. Uslu, and S. A. Ozkan, Chromatographia, 66, 97 (2007)
  • [12] B. Topal, S.A. Ozkan, and B. Uslu, Chromatographia, 66, 25 (2007)
  • [13] K. Heinig, T. Wirz, A. Gajate-Perez, and S. Belli, J. Chromatogr. B, 879, 436 (2011)
  • [14] O. Singh, S. Saxena, S. Mishra, A. Khuroo, and T. Monif, Clinical Biochemistry, 44, 907 (2011)
  • [15] H.R. Xu, X.N. Li, W.L. Chen, G.Y. Liu, N.N. Chu, and C. Yu, J. Chromatogr. B, 848, 329 (2007)
  • [16] S. Singh and M. Bakshi, Pharm. Tech. on-line, 1 (2000)
  • [17] International conference on Harmonization (ICH), Q2 (R1): Validation of Analytical Procedures — Text and Methodology, Geneva, Switzerland, 2005
Typ dokumentu
Bibliografia
Identyfikator YADDA
bwmeta1.element.baztech-18e39b5d-2433-49e6-8021-a20f75a652a0
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