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

Authors :
Komsta, Ł.
Medical University of Lublin Chair and Department of Medicinal Chemistry, Faculty of Pharmacy Jaczewskiego 4 20-090 Lublin Poland, lukasz.komsta@am.lublin.pl,
Gowin, E.
Medical University of Lublin Chair and Department of Medicinal Chemistry, Faculty of Pharmacy Jaczewskiego 4 20-090 Lublin Poland,
Djordjević Filijović, N.
Hemofarm AD Vrsac Serbia,
Pavlović, A.
Hemofarm AD Vrsac Serbia,
Nikolić, K.
University of Belgrade, Faculty of Pharmacy Department of Pharmaceutical Chemistry Vojvode Stepe 450 PO Box 146 11000 Belgrade Serbia,
Agbaba, D.
University of Belgrade, Faculty of Pharmacy Department of Pharmaceutical Chemistry Vojvode Stepe 450 PO Box 146 11000 Belgrade Serbia, danica@pharmacy.bg.ac.rs,
Sawant, S.
Sinhgad Technical Education Society’s Smt. Kashibai Navale College of Pharmacy, Kondhwa (Bk.) Pune 411 048 Maharashtra India, sawant99@rediffmail.com,
Barge, V.
PDEA’s Seth Govind Raghunath Sable College of Pharmacy Saswad, Tal-Purandar, Dist-Pune 412301 Maharashtra India,
Abstract : 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.

Keywords : valganciclovir, stress degradation, stability indicating assay method, HPLC, LC-MS,
Publishing house : University of Silesia in Katowice
Publication date : 2014
Number : Vol. 26, no. 1
Page : 29 – 42

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DOI :
Qute : Komsta, Ł. ,Gowin, E. ,Djordjević Filijović, N. ,Pavlović, A. ,Nikolić, K. ,Agbaba, D. ,Sawant, S. ,Barge, V. ,Barge, V. , A validated stability indicating RP-HPLC method for valganciclovir, identification and characterization of forced degradation products of valganciclovir using LC-MS/MS. Acta Chromatographica Vol. 26, no. 1/2014
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