Method for determining cvortioxetine intermediate and its isomers by using liquid chromatography
A technology of isomers and determination methods, which is applied in the directions of measuring devices, material separation, and analysis materials, etc., can solve problems such as incomplete removal of isomers, side reactions, and influence on drug purity and quality, and achieve improvement Yield and purity, reduced side reactions, quality-controlled effects
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Embodiment 1
[0037] Instruments and Conditions
[0038] LC-20AT pump, SPD-M20A detector, SIL-20AC autosampler, CBM-20A controller, CTO-10ASVP column thermostat, LC solution workstation
[0039] Chromatographic column: Welch (Ultimate PFP, 250×4.6mm, 5μm)
[0040] Mobile phase: A: 0.02mol / L dipotassium hydrogen phosphate buffer solution (adjust pH to 6.5 with phosphoric acid); B: methanol;
[0041] Elution was performed with the following gradient:
[0042]
[0043] Flow rate: 1.5mL / min
[0044] Detection wavelength: 220nm
[0045] Column temperature: 40°C
[0046] Injection volume: 10μL
[0047] Experimental procedure
[0048] Take an appropriate amount of vortioxetine hydrobromide intermediate and its isomers, dissolve the sample with methanol, and prepare each 1mL containing about 0.5 mg of vortioxetine hydrobromide intermediate and its isomers sample solution. Take an appropriate amount of the above-mentioned vortioxetine hydrobromide intermediate and its isomer solution to p...
Embodiment 2
[0050] Instruments and Conditions
[0051] High performance liquid chromatography: Shimadzu: LC-20AT pump, SPD-M20A detector, SIL-20AC autosampler, CBM-20A controller, CTO-10ASVP column thermostat, LC solution workstation
[0052] Chromatographic column: Kromasil (100-5PHENYL, 250×4.6mm, 5μm)
[0053] Mobile phase: A: 1% triethylamine aqueous solution (adjust pH to 6.5 with phosphoric acid), B: methanol;
[0054] T(min) 0 15 35 53 53.01 65 B% 25 30 60 60 25 25
[0055] Flow rate: 1.5mL / min
[0056] Detection wavelength: 220nm
[0057] Column temperature: 40°C
[0058] Injection volume: 10μL
[0059] Experimental procedure
[0060] Take an appropriate amount of vortioxetine hydrobromide intermediate and its isomers, dissolve the sample with methanol, and prepare each 1mL containing about 0.5 mg of vortioxetine hydrobromide intermediate and its isomers sample solution. Take an appropriate amount of the above-mentioned vortioxetine hydrobromi...
Embodiment 3
[0062] Instruments and Conditions
[0063] High performance liquid chromatography: Shimadzu: LC-20AT pump, SPD-M20A detector, SIL-20AC autosampler, CBM-20A controller, CTO-10ASVP column thermostat, LC solution workstation
[0064] Chromatographic column: Agilent (ZORBAX SB-Phenyl, 250×4.6mm, 5μm)
[0065] Mobile phase: A: 0.05mol / L potassium dihydrogen phosphate buffer solution (adjust the pH to 6.5 with potassium hydroxide); B: methanol;
[0066] T(min) 0 15 35 55 55.01 65 B% 30 35 70 70 30 30
[0067] Flow rate: 1.5mL / min
[0068] Detection wavelength: 220nm
[0069] Column temperature: 40°C
[0070] Injection volume: 10μL
[0071] Experimental procedure
[0072] Take an appropriate amount of vortioxetine hydrobromide intermediate and its isomers, dissolve the sample with methanol, and prepare respectively about 0.5 mg of each 1 mL of vortioxetine hydrobromide intermediate and its isomers. sample solution. Take an appropriate amount of t...
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