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Effect of the long-term storage methods on the stability of cartilage biomechanical parameters
Žaloudková, Blanka ; Sekorová, Š. ; Kopecká, B. ; Kytýř, Daniel
Long-term stability of the tissue product in terms of mechanical parameters is a key factor for its expiration date. For the investigation of storage effects on the cartilage tissues the experimental mechanical loading test combined with XCT scanning for the irregular shape inspection was performed. The samples were preserved according to three different protocols using the deep-freezing and two types of saline solution preservation. The stability of the biomechanical parameters was tested within annual intervals. All samples were subjected to uni-axial compression loading using the in-house developed compact table top loading device in displacement-driven mode. Based on the measurements, the results are represented in the form of stress-strain curves and quantified as elastic modulus and ultimate compression stress. It can be concluded that no significant difference was found in neither the mechanical properties of the samples nor in the effects of each preservational method.
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Analysis of active pharmaceutical ingredient vemurafenib by LC
Filounová, Barbora ; Kozlík, Petr (advisor) ; Křížek, Tomáš (referee)
The aim of this work was to develop and optimize liquid chromatography method with spectrophotometric detection applicable to assay and purity of vemurafenib in solid dosage form and perform its stability study. The optimized separation conditions consisted of Poroshell HPH-C18 (3 × 100 mm, 2.7 μm) column tempered at 30 žC, mobile phase composed of 10 mM ammonium phosphate, pH 3,0/acetonitrile. Flow rate was set at 0.6 mL/min and gradient elution was performed. Detection wavelength was 250 nm. The calibration curve of vemurafenib was constructed in the concentration range 0.4 - 1.2 mg/mL. Limit of detection was 5.0 µg/mL and limit of quantitation was 16.5 µg/mL. Stability and stress tests of vemurafenib were performed under several conditions: Heat (80 žC), heat combined with humidity (80 žC/75 % relative humidity), hydrochloric acid (0,1 M), sodium hydroxide (0,1 M) and hydrogen peroxide (3% and 0,3% solution). The significant degradation of vemurafenib was observed under acid condition. Vemurafenib also degradated under oxidation condition. No degradation was observed under base condition and under heat and heat combined with humidity. Degradation of vemurafenib was not effected by tested excipients. Judging based on experiments vemurafenib is stable from the point of view of chemical stability.
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Analysis of active pharmaceutical ingredient vemurafenib by LC
Filounová, Barbora ; Kozlík, Petr (advisor) ; Křížek, Tomáš (referee)
The aim of this work was to develop and optimize liquid chromatography method with spectrophotometric detection applicable to assay and purity of vemurafenib in solid dosage form and perform its stability study. The optimized separation conditions consisted of Poroshell HPH-C18 (3 × 100 mm, 2.7 μm) column tempered at 30 žC, mobile phase composed of 10 mM ammonium phosphate, pH 3,0/acetonitrile. Flow rate was set at 0.6 mL/min and gradient elution was performed. Detection wavelength was 250 nm. The calibration curve of vemurafenib was constructed in the concentration range 0.4 - 1.2 mg/mL. Limit of detection was 5.0 µg/mL and limit of quantitation was 16.5 µg/mL. Stability and stress tests of vemurafenib were performed under several conditions: Heat (80 žC), heat combined with humidity (80 žC/75 % relative humidity), hydrochloric acid (0,1 M), sodium hydroxide (0,1 M) and hydrogen peroxide (3% and 0,3% solution). The significant degradation of vemurafenib was observed under acid condition. Vemurafenib also degradated under oxidation condition. No degradation was observed under base condition and under heat and heat combined with humidity. Degradation of vemurafenib was not effected by tested excipients. Judging based on experiments vemurafenib is stable from the point of view of chemical stability.
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