A kind of quality control method of pazufloxacin mesylate and injection preparation
A technique for pazufloxacin mesylate and injection preparations, which is applied in the field of quality control of pazufloxacin mesylate and injection preparations to achieve the effect of precise quantitative determination of impurities
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Embodiment 1
[0022] Example 1: Determination of Dextroisomer in Pazufloxacin Mesylate by HPLC
[0023] Chromatographic conditions and system suitability test: use octadecylsilane bonded silica gel as filler, dissolve in water (take 0.5g of copper sulfate and 0.5g of D-phenylalanine in 0.1mol / L potassium dihydrogen phosphate buffer solution In 2000ml, adjust the pH value to 2.0 with phosphoric acid]-methanol (50:50) as the mobile phase, and the detection wavelength is 293nm.
[0024] Preparation of the test solution: take an appropriate amount of pazufloxacin mesylate sample, add mobile phase to make a solution containing 0.3mg in every 1ml, as the test solution.
[0025] Preparation of contrast solution: Accurately measure 1ml of the test solution, put it in a 200ml measuring bottle, add mobile phase to dilute to the mark, shake well, and use it as contrast solution.
[0026] Preparation of reference substance solution: Take an appropriate amount of pazufloxacin mesylate racemate refere...
Embodiment 2
[0028] Example 2: Determination of Dextroisomer in Pazufloxacin Mesylate by HPLC
[0029] Chromatographic conditions and system suitability test: use octaalkylsilane bonded silica gel as filler, dissolve 0.5g copper sulfate and 0.5g D-phenylalanine in 0.1mol / L potassium dihydrogen phosphate buffer 2000ml In the method, the pH value was adjusted to 6.0 with phosphoric acid]-methanol (80:20) was used as the mobile phase, and the detection wavelength was 293nm.
[0030] Preparation of the test solution: take an appropriate amount of pazufloxacin mesylate sample, add mobile phase to make a solution containing 0.3mg in every 1ml, as the test solution.
[0031] Preparation of contrast solution: Accurately measure 1ml of the test solution, put it in a 200ml measuring bottle, add mobile phase to dilute to the mark, shake well, and use it as contrast solution.
[0032] Preparation of reference substance solution: Take an appropriate amount of pazufloxacin mesylate racemate reference...
Embodiment 3
[0034] Example 3 : Determination of Dextroisomer Content in Pazufloxacin Mesylate by High Performance Liquid Chromatography
[0035] Chromatographic conditions and system suitability test: use octadecylsilane bonded silica gel as filler, dissolve 0.5g copper sulfate and 0.5g D-phenylalanine in 0.1mol / L sodium acetate buffer 2000ml with water , adjust the pH value to 4.0 with phosphoric acid] - acetonitrile (50:50) as the mobile phase, the detection wavelength is 293nm.
[0036] Preparation of the test solution: take an appropriate amount of pazufloxacin mesylate sample, add mobile phase to make a solution containing 0.3mg in every 1ml, as the test solution.
[0037] Preparation of contrast solution: Accurately measure 1ml of the test solution, put it in a 200ml measuring bottle, add mobile phase to dilute to the mark, shake well, and use it as contrast solution.
[0038] Preparation of reference substance solution: Take an appropriate amount of pazufloxacin mesylate racemat...
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