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LC-MS characterization of valsartan degradation products and comparison with LC-PDA BJPS
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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Compatibility and stability of valsartan in a solid pharmaceutical formulation BJPS
Júlio,Tamíris Amanda; Zâmara,Igor Fernando; Garcia,Jerusa Simone; Trevisan,Marcello Garcia.
Valsartan (VAL) is a highly selective blocker of the angiotensin II receptor that has been widely used in the treatment of hypertension. Active pharmaceutical ingredient compatibility with excipients (crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose and titanium dioxide) is usually evaluated in solid pharmaceutical development. Compatibility and stability can be evaluated by liquid chromatography. Studies were performed using binary mixtures of 1:1 (w/w) VAL/excipient; samples were stored under accelerated stability test conditions (40 ºC at 75% relative humidity). The results indicate that VAL is incompatible with crospovidone and hypromellose, which reduced the VAL content and gave rise to new peaks in the chromatogram due to...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Valsartan/compatibility; Valsartan/stability; Hypertension/treatment; Differential Scanning Calorimetry/drug analysis; High performance liquid chromatography/quantitative analysis; Pharmaceutical formulations/quantitative analysis...
Ano: 2013 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502013000400003
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