Method for measuring related alprazolam tablet substances based on high performance liquid chromatography
A high-performance liquid chromatography, alprazolam tablet technology, which is applied in the directions of measuring devices, instruments, scientific instruments, etc., can solve problems such as unpublished detection methods of alprazolam tablets, and achieves convenient quality detection and monitoring, high sensitivity The accuracy of its content is improved, and the effect of high reproducibility
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Embodiment 1
[0044] A method for the determination of related substances in alprazolam tablets by high performance liquid chromatography, using the following conditions for determination:
[0045] Chromatographic column: use octadecylsilane bonded silica gel as filler;
[0046] Mobile phase A: potassium dihydrogen phosphate solution with a concentration of 1.4g / L;
[0047] Mobile phase B: acetonitrile;
[0048] Column temperature: 40°C;
[0049] Detection wavelength: 231nm;
[0050] Flow rate: 1.0mL / min;
[0051] Adopt gradient elution, take the total volume of described mobile phase as 100%,
[0052] At 0 to 10 minutes, the volume of the mobile phase A decreases from 75% to 70%, and the volume of the mobile phase B increases from 25% to 30%;
[0053] At 10 to 30 minutes, the volume of the mobile phase A is 70%, and the volume of the mobile phase B is 30%;
[0054] At 30 to 60 minutes, the volume of the mobile phase A decreases from 70% to 50%, and the volume of the mobile phase B in...
experiment example 1
[0060] Experimental Example 1 System Suitability Test
[0061] Diluent: water and acetonitrile in a volume ratio of 1:1.
[0062] Blank excipient solution: Accurately weigh 500 mg of blank excipient (composed of starch, sucrose, dextrin and magnesium stearate with a mass ratio of 31:39:9:1), put it in a 10ml measuring bottle, add diluent to dissolve and dilute to scale, shake well, filter, and take the filtrate as the blank excipient solution.
[0063] Preparation of mixed control solution: take alprazolam and impurity A, triazolam, 7-chloro-1,3-dihydro-5-phenyl-2H-1,4-benzodiazepin-2-one , 7-chloro-1,3-dihydro-5-phenyl-2H-1,4-benzodiazepine-2-thione, appropriate amount of impurity E, add diluent to dissolve and dilute to make each 1mL containing Alprazolam, impurity A, triazolam, 7-chloro-1,3-dihydro-5-phenyl-2H-1,4-benzodiazepin-2-one, 7-chloro-1, 3-dihydro-5-phenyl-2H-1,4-benzodiazepine-2-thione and 20 μg of impurity E were filtered, and the subsequent filtrate was used ...
experiment example 2
[0073] Experimental example 2 linearity and range test
[0074] Linear stock solution: Accurately measure alprazolam, impurity A, triazolam, 7-chloro-1,3-dihydro-5-phenyl-2H-1,4-benzodiazepine-2- An appropriate amount of ketone and impurity E were respectively prepared with a diluent (the diluent is water and acetonitrile with a volume ratio of 1:1) to prepare a solution with a concentration of 10 μg / mL.
[0075] Linear 1 solution: Accurately measure 0.4mL, 0.6mL, 0.75mL, 0.9mL, 1.125mL, 1.5mL of impurity A and impurity E linear stock solutions respectively, put them in different 20mL measuring bottles, and use the diluent respectively (the diluent is Water and acetonitrile with a volume ratio of 1:1) diluted to the mark and shaken to obtain linear 1 solutions ①②③④⑤⑥⑥ respectively.
[0076] Linear 2 solution: Accurately measure 0.2 mL each of triazolam, 7-chloro-1,3-dihydro-5-phenyl-2H-1,4-benzodiazepin-2-one linear stock solution, Alprazolam linear stock solution 0.1mL, put...
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