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| Pires,Sumaia Araújo; Mota,Letícia Martins; Garcia,Jerusa Simone; Amaral,Phellipe Honorio; Meurer,Eduardo César; Eberlin,Marcos Nogueira; Trevisan,Marcello Garcia. |
| abstract Valsartan was submitted to forced degradation under acid hydrolysis condition as prescribed by the ICH. Degraded sample aliquots were separated via HPLC using a Hypersil ODS (C18) column (250 x 4.6 mm i.d., 5 µm). Either photodiode array (PDA) detection or mass spectrometry (MS) full scan monitoring of HPLC runs were used. HPLC-PDA failed to indicate Valsartan degradation under forced acid degradation, showing an insignificant peak area variation and that Valsartan apparently remained pure. HPLC-MS using electrospray ionization (ESI) and total ionic current (TIC) monitoring did not reveal any peak variation either, but inspection of the ESI mass spectra showed the appearance of m/z 306 and m/z 352 ions for the same retention time as that of... |
| Tipo: Info:eu-repo/semantics/article |
Palavras-chave: Valsartan; Stress testing; Degradation products; Stability-indicating; Acidic hydrolysis. |
| Ano: 2015 |
URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502015000400839 |
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