Method for analyzing and detecting impurities in ornithine aspartate
A detection method and impurity technology, applied in the field of analytical chemistry, can solve the problem of not clearly recording quantitative and qualitative methods, etc., and achieve the effects of high sensitivity, low detection limit, and easy operation.
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Embodiment 1
[0043] The preparation of embodiment 1 ornithine
[0044] Take 10 g of free ornithine, reflux reaction in aqueous solution for 5 hours, concentrate to dryness under reduced pressure at 60 ° C, stir in 30 g of silica gel for column chromatography, and separate by forward column chromatography (500 g of silica gel, CH 2 Cl 2 :CH 3 OH is the eluent, the volume ratio is 1:1v / v), the ninhydrin is collected as a yellow component, the pH is adjusted to 1 by adding hydrochloric acid, concentrated into a slurry, crystallized by adding ethanol, and dried by suction filtration. Ornithine Hydrochloride.
Embodiment 2
[0046] Chromatographic conditions:
[0047] Using octadecyl bonded silica gel as a filler, the mobile phase is 0.1mol / L potassium dihydrogen phosphate (containing 0.1% sodium heptanesulfonate) solution-acetonitrile (95:5v / v), the flow rate is 1ml / min, and the detection The wavelength is 205nm, chromatographic column: Kromsil 150*4.6, 5um, 100AC 18 Column; column temperature 30°C, injection volume: 20 μl.
[0048] Preparation of the test solution:
[0049] Take 96.8 mg of ornithine aspartate, accurately weigh it, put it in a 25ml measuring bottle, add mobile phase to dissolve and dilute to the mark, and use it as ornithine aspartate sample solution.
[0050]Take 98.30 mg of ornithine aspartate freeze-dried powder injection, accurately weigh it, put it in a 25ml measuring bottle, add mobile phase to dissolve and dilute to the mark, and use it as the sample solution of ornithine aspartate injection.
[0051] Reference substance solution preparation:
[0052] Take 40.50mg of o...
Embodiment 3
[0057] Chromatographic conditions: Octadecyl bonded silica gel as filler, mobile phase 0.05mol / L potassium dihydrogen phosphate (containing 0.1% sodium heptanesulfonate) solution-acetonitrile (93:7v / v), flow rate 1mL / min, detection wavelength is 210nm, chromatographic column: Kromsil150*4.6, 5um, 100AC 18 Column; column temperature 30°C, injection volume: 20 μl.
[0058] Preparation of the test solution:
[0059] Get ornithine aspartic acid injection (99.10mg by aspartic acid ornithine), add mobile phase and be made into a solution containing about 10mg / mL ornithine aspartate, as ornithine aspartate Acid injection sample solution.
[0060] Reference substance solution preparation:
[0061] Take 59.30mg of ornithine hydrochloride, accurately weigh it, put it in a 10ml measuring bottle, add water to dissolve and dilute to the mark, shake well, then accurately measure 5ml, place it in a 100ml measuring bottle, add water to dilute to the mark.
[0062] Take 20 μl each and inj...
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Abstract
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