Application of solid-phase extraction column in analysis of tacrolimus preparation impurities
A technology of solid phase extraction column and tacrolimus, which is applied in the application field of solid phase extraction column in the analysis of impurities in tacrolimus ointment, can solve the problems of separation of tacrolimus and its related substances, and achieves safety Effective control of sex and precise control of impurities
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Embodiment 1
[0039] A kind of application of solid phase extraction column in tacrolimus preparation impurity analysis, comprises the following steps:
[0040]a) Rinse the centrifuge tube and the pear-shaped bottle twice with methanol, 5ml each time, and dry them for later use; b) Weigh about 1.0g of tacrolimus blank preparation and tacrolimus preparation samples, 7 samples each, and set In a stoppered glass centrifuge tube; c) Add 5ml of n-hexane-ethyl acetate (10:1) mixed solution to the centrifuge tube respectively, shake vigorously until the suspension is complete; d) Centrifuge at a speed of 3000 rpm for 5 minutes , the supernatant is used as the liquid to be purified; e) the glycol-based silane bonded silica gel solid-phase extraction column is Agilent BondElute 2OH 6cc / 500mg, Waters Sep-Pak 6cc / 500mg, Simon Aldrich Classic 6cc / 500mg, Welchrom 6cc / 500mg , CNWBOND 6cc / 500mg, Merck 6cc / 500mg, Supelco 6cc / 500mg two each, rinse with 5ml of acetonitrile respectively, then rinse twice with...
Embodiment 2
[0044] A kind of application of solid phase extraction column in tacrolimus preparation impurity analysis, comprises the following steps:
[0045] a) Rinse the centrifuge tube and pear-shaped bottle twice with methanol, 5ml each time, and dry for later use; b) Weigh about 1.0 g of tacrolimus blank preparation, 8 parts, and put them in glass centrifuge tubes with stoppers; c ) respectively add 1ml of the mixed reference substance solution to the centrifuge tube, then add 4ml of the mixed solution of n-hexane-ethyl acetate (10:1), shake vigorously until the suspension is complete; d) Centrifuge at a speed of 3000 rpm for 5 minutes , the supernatant is used as the liquid to be purified; e) Take glycol-based silane-bonded silica gel SPE columns Agilent BondElute 2OH 6cc / 500mg, Waters Sep-Pak 6cc / 500mg, Simon Aldrich Classic 6cc / 500mg, Welchrom 6cc / 500mg, CNWBOND 6cc / 500mg, Merck6cc / 500mg, Supelco 6cc / 500mg two each, rinse with 5ml of acetonitrile respectively, then rinse twice wit...
Embodiment 3
[0051] A kind of application of solid phase extraction column in tacrolimus preparation impurity analysis, comprises the following steps:
[0052] a) Rinse the centrifuge tube and the pear-shaped bottle twice with methanol, 5ml each time, and dry it for later use; b) Weigh about 0.5g of tacrolimus blank preparation, 6 parts, and put them in glass centrifuge tubes with stoppers; c ) into 4 centrifuge tubes, add 0.5ml of the mixed reference substance solution, then add 2.5ml of the mixed solution of n-hexane-ethyl acetate (10:1), add n-hexane-ethyl acetate to the other 2 centrifuge tubes respectively (10:1) mixed solution 3ml, shake vigorously until the suspension is complete; d) centrifuge at a speed of 3000 rpm for 5 minutes, and the supernatant is used as the liquid to be purified; e) take a glycol silane bonded silica gel solid phase Extraction column Waters Sep-Pak Diol different specification 1cc / 100mg, 3cc / 200mg each 3 pieces, rinse with 3ml of acetonitrile respectively, ...
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