Person: TIRIS, GİZEM
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GİZEM
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TIRIS
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Publication Metadata only Development of a green high-performance liquid chromatography method for tofacitinib quantification in pharmaceutical formulations and degradation studies(2024-04-02) TIRIS G.; Genc A. A.; ERK N.; TIRIS, GİZEMA new high-performance liquid chromatography (HPLC) method was applied for the quantification of the active substance of tofacitinib. Analysis was performed on a Chromasil 100 C18 (100.0 x 4.0 mm, 3.5 mu m) stationary phase. The mobile phase consisted of acetonitrile:0.2% phosphoric acid in water (12:88, v/v). The prepared sample (20.0 mu L) was injected into the system. A detection wavelength of 285.0 nm was chosen for the compound, and the flow rate was 0.8 mL/min. The experiment was completed in 5.0 min. The analysis temperature was set to 40.0 degrees C. The method was evaluated using green chemistry. The method was validated according to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines. For linearity studies calibration curves were constructed in the range of 10.0-200.0 mu g/mL. The recovery values were calculated at 97.66% and 105.68%. The method developed for the analysis of the active substance had a short analysis time and was cost-effective. It is an environmentally friendly method due to the mobile phase content used. The technique can be used in laboratory analysis and bioequivalence experiments.Publication Metadata only Simultaneous analysis of sacubitril and valsartan by novel analytical methods with green approach(2024-04-01) TIRIS G.; Ayse Genc A.; ERK N.; TIRIS, GİZEMA novel high performance liquid chromatography (HPLC) and spectrophotometric analysis were applied for quantification of active substances of sacubitril (SAC) and valsartan (VAL). HPLC experiments were conducted on the Waters Spherisorb® (3.0 µm 60.0x4.0 mm) column. Preparation of mobile phase A: 200 mL of 0.1 % solution of trifluoroacetic acid in water and 800 mL of 0.1 % solution of trifluoroacetic acid in acetonitrile by volume are mixed. Preparation of mobile phase B: 800 mL of a 0.1 % solution of trifluoroacetic acid in water and 200 mL of 0.1 % solution of trifluoroacetic acid in acetonitrile by volume were mixed. It was given to the system at the ratio of Mobile Phase A: Mobile Phase B (35:65 v:v). The specimen was injected into the column at 15.0 µL. A detection wavelength of 254.0 nm was preferred for the compound and the flow rate was 2.0 mL/min. Analysis was completed in 4.0 min. The column oven temperature was adjusted to 40.0 °C. The methods were evaluated in terms of green chemistry. The methods have been validated according to ICH guidelines. For HPLC method calibration graphs were constructed in the 20.0– 145.0 and 20.0 – 155 µg/mL SAC and VAL respectively with an R2 of 1.000. In recovery experiments, the RSD values were calculated to be 0.08 % and 0.34 % for SAC and VAL, respectively. Additionally, in intraday and interday experiments, percent RSD values were found to be between 0.23 and 0.49. The method developed for the analysis of the active substances has been developed with a short analysis time and is cost effective. SAC and VAL were determined using a novel method for spectrophotometric analysis. The determination was performed simultaneously using the applied method. This method is a constant center method. Calibration graphs were constructed in the 2.0– 20.0 and 2.0 – 25 µg/mL SAC and VAL with an R2 of 0.9998 and 0.9999 respectively. It is a greenness method in terms of the analysis time and solvent used.