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

• Autorzy: Sawant S. , Barge V.
• 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.

Słowa kluczowe

EN

valganciclovir; stress degradation; stability indicating assay method; HPLC; LC-MS

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2014
• Tom: Vol. 26, no. 1
• Strony: 29--42
• Opis fizyczny: Bibliogr. 17 poz., rys., tab.

Twórcy

autor

Sawant S.

• Sinhgad Technical Education Society’s Smt. Kashibai Navale College of Pharmacy, Kondhwa (Bk.) Pune 411 048 Maharashtra India

autor

Barge V.

• PDEA’s Seth Govind Raghunath Sable College of Pharmacy Saswad, Tal-Purandar, Dist-Pune 412301 Maharashtra India

Bibliografia

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