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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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| Çelebier,Mustafa; Kaynak,Mustafa Sinan; Altınöz,Sacide; Sahin,Selma. |
| A simple, rapid and reproducible HPLC method was developed for the simultaneous determination of amlodipine and valsartan in their combined dosage forms, and for drug dissolution studies. A C18 column (ODS 2, 10 μm, 200 x 4.6 mm) and a mobile phase of phosphate buffer (pH 3.6 , 0.01 mol L-1):acetonitrile: methanol (46:44:10 v/v/v) mixture were used for separation and quantification. Analyses were run at a flow-rate of 1 mL min-1 and at ambient temperature. The injection volume was 20 μL and the ultraviolet detector was set at 240 nm. Under these conditions, amlodipine and valsartan were eluted at 7.1 min and 3.4 min, respectively. Total run time was shorter than 9 min. The developed method was validated according to the literature and found to be linear... |
| Tipo: Info:eu-repo/semantics/article |
Palavras-chave: Amlodipine besylate; Valsartan; High Performance Liquid Chromatography; Method Development; Validation; Dissolution Study. |
| Ano: 2010 |
URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502010000400018 |
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