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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; Reçber,Tuba; Koçak,Engin; Altinöz,Sacide. |
| Rivaroxaban, an anti-clotting medication, acts at a crucial point in the blood-clotting process and stops the formation of blood clots. In this study, RP-HPLC method was developed for the determination of rivaroxaban in tablets (Xarelto® (10 mg)). Phenomenex Luna 5 µm C18 100 Å LC Column (250 x 4.6 mm) was used at 40 ºC. Isocratic elution was performed with ACN:Water (55:45 v/v) mixture. The flow rate was 1.2 mL min-1 and UV detection was at 249 nm. Internal standard (Caffeine) and rivaroxaban were eluted within 2.21 and 3.37 minutes, respectively. The developed method was validated according to the ICH guidelines and found to be linear within the range 0.005 - 40.0 µg mL-1. The method was accurate, precise, robust and rapid. Thus, it was applied... |
| Tipo: Info:eu-repo/semantics/article |
Palavras-chave: HPLC; Rivaroxaban; Validation; System suitability; Stability-indicating; Pharmaceutical dosage form. |
| Ano: 2013 |
URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502013000200018 |
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| Mathew,Ceema; Swathi,Bellamkonda; Ajitha,Makula; Babu,Puvvadi Sathesh. |
| ABSTRACT The present work describes the development of a new high performance liquid chromatographic (HPLC) method for the determination of Cefixime trihydrate under different stress conditons as specified by ICH. For the analysis, a Phenomenex (250 x 4.6 mm, 5 µm particle size) ODS column and a SPD 20 A UV detector at 289 nm was used. The selected mobile phase was 10 mM disodium hydrogen phosphate (with 0.5% TEA, pH adjusted to 6.3 with OPA) and methanol in the ratio of 75:25 (v/v) in isocratic mode at a flow rate of 1 mL.min-1.The linear regression analysis data for the calibration plots showed good linear relationship with r2 = 0.9997 in the concentration range of 5-100 μg.mL-1. The stress degradation was performed using acid, alkali, water, hydrogen... |
| Tipo: Info:eu-repo/semantics/article |
Palavras-chave: High Performance Liquid Chromatography/quantitative analysis; Degradation; Stability-indicating; Cefixime trihydrate/determination.. |
| Ano: 2016 |
URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502016000100010 |
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| Tolić,Ljiljana; Grujić,Svetlana; Laušević,Mila. |
| ABSTRACT Multifunctional drug anisomycin was subjected to forced degradation in accordance with International Conference on Harmonisation (ICH) guidelines for the first time. The drug was exposed to the recommended stress conditions of hydrolysis (acidic, alkaline and neutral), oxidation, thermal stress and photolysis, in order to investigate its stability. Optimized LC-MS/MS method was validated as recommended by ICH Q2(R1) guideline with respect to the specificity, accuracy, precision, limits of detection and quantitation, linearity and robustness. Anisomycin exhibited high instability under alkaline and thermal (neutral hydrolysis) conditions. It showed moderate stability under acidic, neutral, oxidative, thermal (acidic hydrolysis) and photolytic... |
| Tipo: Info:eu-repo/semantics/article |
Palavras-chave: Anisomycin/forced degradation; Stability-indicating; LC-MS/MS/validation; Deacetylanisomycin. |
| Ano: 2018 |
URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502018000200607 |
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