คำศัพท์เฉพาะทางเคมี3.7. System suit

คำศัพท์เฉพาะทางเคมี3.7. System suitability study
System suitability tests were carried out on a freshly prepared standard solution of the Met, Saxa and Sita to scrutinize the various optimized parameters. Such as plate count, resolution and tailing factor.

3.8. Robustness study
The robustness of the method was studied by negligible variations in the technique such as altering the wavelength of detection, flow rate, column temperature and changes in composition of the mobile phase.
4. Degradation studies
The International Conference on Harmonization (ICH) guideline entitled stability testing of new drug substances and products requires that stress testing be carried out to elucidate the inherent stability characteristics of the active substance. The goal of this work was to carry out the stress degradation studies on the Met, Saxa & Sita using the proposed method.
4.1. Standard solution preparation
Standard solution of Met, Saxa & Sita were prepared to get concentration of 200, 2, 20 mg/mL respectively.
4.2. Hydrolytic degradation in acidic condition
From above stock solution, pipette out 2.0 mL, 0.2 mL and 0.2 mL of the Met, Saxa and Sita in 10 mL of volumetric flask and added 1 mL of 0.1 N HCl to it. Then, the volumetric flask was kept in a water bath at 60e70 C for 1 h and neutralized with 0.1 N NaOH. Finally, make up to 10 mL with diluents to get concentration of 200, 2, 20 mg/mL of the Met, Saxa and Sita respectively. Cool the solution to room temperature. Filter the solution with 0.45 micron syringe filters and place in vials of the HPLC system.
4.3. Hydrolytic degradation in alkaline condition
From above stock solution, pipette out 2.0 mL, 0.2 mL and 0.2 mL of the Met, Saxa and Sita in 10 mL of volumetric flask and added 1 mL of 0.1 N NaOH to it. Then, the volumetric flask was kept in a water bath at 60 70 C for 1 h and neutralized with 0.1 N HCl. Finally, make up to 10 ml with diluents to get concentration of 200, 2, 20 mg/mL of the Met, Saxa & Sita respectively. Cool the solution to room temperature. Filter the solution with 0.45 micron syringe filters and place in vials of the HPLC system.
4.4. Thermally induced degradation
From above stock solution, pipette out 2.0 mL,
0.2 mL and 0.2 mL of the Met, Saxa and Sita in 10 mL of volumetric flask and added 3 mL of diluent to it. Then, volumetric flask was kept in hot air oven at 60e70 C for 1 h. Finally, make up to 10 mL with diluents to get concentration of 200, 2, 20 mg/mL of the Met, Saxa & Sita respectively. Cool the solution to room temperature. Filter the solution with 0.45 micron syringe. Filters and place in vials of the HPLC system. 4.5. Oxidative degradation
From above stock solution, pipette out 2.0 mL,0.2 mL and 0.2 mL of the Met, Saxa & Sita in 10 mL of volumetric flask and added 1 mL of 3% w/v Hydrogen peroxide to it. Then, the volumetric flask was made up to 10 mL with diluents to get concentration of 200, 2, 20 mg/mL of the Met, Saxa and Sita respectively and kept aside for 30 min. Filter the solution with 0.45 micron syringe filters and place in vials of the HPLC system respectively.
4.6. Photo degradation
From above stock solution, pipette out 2.0 mL, 0.2 mL and 0.2 mL of the Met, Saxa and Sita in 10 mL volumetric flask. Then, the samples were transferred into a petri dish and kept in Photostability chamber 200 Wh/m2 in UV light and 1.2 million l h in visible light for 5 h. Finally, volumetric flask was made up to 10 mL with diluents to get concentration of 200, 2 , 20 mg/mL of the Met, Saxa and Sita respectively. Cool the solution to room temperature. Filter the solution with 0.45 micron syringe and place in v

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Chemical Terminology 3.7. System SUITABILITY Study
System SUITABILITY tests were carried out on a freshly prepared standard Solution of the Met, Saxa and Sita to Scrutinize the Various Optimized Parameters. Such as Plate Count, resolution and tailing factor. 3.8. Robustness Study The robustness of the method was studied. by negligible variations in the Technique such as altering the wavelength of detection, flow rate, column Temperature and changes in composition of the Mobile Phase. 4. Degradation Studies The International Conference on Harmonization (ICH) Guideline Testing of New Drug Substances and stability Entitled Products. requires that stress Testing be carried out to Elucidate the inherent stability characteristics of the active substance. The Goal of this Work was to Carry out the stress degradation Studies on the Met, Saxa & Sita using the Proposed method. 4.1. Standard Solution Preparation Standard Solution. of Met, Saxa & Sita were prepared to Get concentration of 200, 2, 20 mg / mL respectively. 4.2. Hydrolytic degradation in acidic condition From above Stock Solution, Pipette out 2.0 mL, 0.2 mL and 0.2 mL of the Met, Saxa and. Sita in 10 mL of volumetric flask and added 1 mL of 0.1 N HCl to it. Then, the volumetric flask was kept in a water bath at 60e70 C for 1 h and neutralized with 0.1 N NaOH. Finally, make up to 10 mL with. diluents to Get concentration of 200, 2, 20 mg / mL of the Met, Saxa and Sita respectively. Cool the Solution to Room Temperature. Filter the Solution with 0.45 Micron syringe Filters and Place in vials of the HPLC System. 4.3. Hydrolytic degradation. in alkaline condition From above Stock Solution, Pipette out 2.0 mL, 0.2 mL and 0.2 mL of the Met, Saxa and Sita in 10 mL of volumetric Flask and added 1 mL of 0.1 N NaOH to it. Then, the volumetric Flask was kept in. a water bath at 60 70 C for 1 h and neutralized with 0.1 N HCl. Finally, make up to 10 ml with diluents to get concentration of 200, 2, 20 mg / mL of the Met, Saxa & Sita respectively. Cool the solution. to Room Temperature. Filter the Solution with 12:45 a.m. Micron syringe Filters and Place in vials of the HPLC System. 4.4. Thermally induced degradation From above Stock Solution, Pipette out 2.0 mL, 0.2 mL and 0.2 mL of the Met, Saxa and Sita in 10. mL of volumetric flask and added 3 mL of diluent to it. Then, volumetric flask was kept in hot air oven at 60e70 C for 1 h. Finally, make up to 10 mL with diluents to get concentration of 200, 2, 20 mg /. mL of the Met, Saxa & Sita respectively. Cool the Solution to Room Temperature. Filter the Solution with twelve forty-five a.m. Micron syringe. Filters and Place in vials of the HPLC System. 4.5. Oxidative degradation From above Stock Solution, Pipette out 2.0 mL, 0.2. mL and 0.2 mL of the Met, Saxa & Sita in 10 mL of volumetric flask and added 1 mL of 3% w / v Hydrogen peroxide to it. Then, the volumetric flask was made ​​up to 10 mL with diluents to get concentration of 200. , 2, 20 mg / mL of the Met, Saxa and Sita respectively and kept aside for 30 min. Filter the Solution with 0:45 Micron syringe Filters and Place in vials of the HPLC System respectively. 4.6. Photo degradation From above Stock Solution, Pipette. out 2.0 mL, 0.2 mL and 0.2 mL of the Met, Saxa and Sita in 10 mL volumetric flask. Then, the samples were transferred into a petri dish and kept in Photostability chamber 200 Wh / m2 in UV light and 1.2 million lh in visible. light for 5 h. Finally, volumetric flask was made ​​up to 10 mL with diluents to get concentration of 200, 2, 20 mg / mL of the Met, Saxa and Sita respectively. Cool the solution to room temperature. Filter the solution with 0.45. micron syringe and place in v