Analytical method of tedizolid phosphate and related substances thereof
A technology of tedizolid phosphate and analysis method, which is applied in the directions of analysis materials, material separation, measuring devices, etc., can solve the problems such as no loading of tedizolid phosphate, and achieve the effects of good specificity, improved work efficiency and low cost
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Embodiment 1
[0039] High performance liquid chromatography analysis of embodiment one tedizolid phosphate and several related substances
[0040] Several related substances are: BP13, BP20, BP22, BP23, BP25, BP26, BP42, DDG02, DDG14, INA, INA08, SMA, TDPEN
[0041] Instruments and analysis conditions——Shimadzu 2010 or Agilent1100 for high-performance liquid chromatography; Waters Xterra C18 (150*4.6mm, 3.5μm) for chromatographic column; octadecylsilane bonded silica gel as filler; detection wavelength is 300nm; with 25mmol / L ammonium acetate (adjust pH to 8.5 with ammonia water) as mobile phase A, with acetonitrile:tetrahydrofuran (90:10) as mobile phase B, flow rate is 1.0ml / min; column temperature is 40°C; theoretical plate The number is not less than 3000 based on the peak of tedizolid phosphate; carry out gradient elution according to the following table:
[0042] time (min) Mobile phase A(%) Mobile phase B(%) 0 99 1 30 53 47 40 53 47 42 99 1 5...
Embodiment 2
[0054] The methodological investigation of the analytical method of the present invention of embodiment two
[0055] 1. System applicability inspection
[0056] Solution preparation:
[0057] Resolution test solution: Take an appropriate amount of BP13, BP20, BP22, BP23, BP25, BP26, BP42, DDG02, DDG14, INA, INA08, SMA and tedizolid phosphate reference substance respectively, add mobile phase A to make quantitative dilution into each 1ml A mixed solution containing 1.25 μg of other impurities and 250 μg of tedizolid phosphate was used as the resolution solution.
[0058] Need testing solution: Take about 25 mg of tedizolid hydrochloride phosphate reference substance, accurately weigh it, put it in a 100ml measuring bottle, add mobile phase A to dissolve and dilute to the scale, shake well, and use it as the testing solution;
[0059] Control solution: Accurately measure 1ml of the test solution, put it in a 200ml measuring bottle, add mobile phase A to dilute to the mark, sha...
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