Detection method of brexpiprazole starting material related substances
A detection method, ebiprazole technology, applied in the field of detection of related substances in ebiprazole starting materials, can solve the problems of incomplete detection and control of impurities, and achieve appropriate detection time, high precision, and good stability Effect
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Embodiment 1
[0063] Embodiment 1 Detection method of the present invention
[0064](1) Preparation of impurity reference substance solution Take 3mg of each of the related substances A1-1, A1-2, A1-3, and A1-4, add diluent to dissolve and set the volume to 100mL, shake well, and use it as impurity mixed stock solution; precision Measure 5mL of impurity mixed stock solution, place it in a 50mL measuring bottle, add diluent to make up to the mark, shake well, and use it as the impurity reference substance mixed solution.
[0065] (2) Preparation of the test solution Weigh 7.5mg of this product, place it in a 25mL measuring bottle, add diluent to dissolve and dilute to the mark, shake well, and use it as the test solution.
[0066] (3) Determination method: Accurately measure 20 μl each of the test solution and the impurity reference solution, inject them into the liquid chromatograph respectively, and record the chromatograms. The chromatographic conditions are as follows:
[0067] Chromat...
Embodiment 2
[0075] Embodiment 2 detection method process screening of the present invention
[0076] 1. Determine the detection wavelength
[0077] Precisely weigh the appropriate amount of ebiprazole starting material 1 and impurities A1-1, A1-2, A1-3, and A1-4, and use solvent (methanol) to prepare a sample and impurity reference solution containing 5 μg per 1 mL ,spare.
[0078] The test solution of the above-mentioned ebiprazole starting material 1 and the reference solution of each impurity were scanned in the range of 200-400nm, and the results are shown in Table 1.
[0079] Table 1
[0080] No. Peak wavelength(nm) the peak Valley wavelength(nm) valley Starting material 1 213.2 1.515 335 0.364 Impurity A1-1 215.2 1.033 278.6 0.104 Impurities A1-2 216.8 1.26 239.4 0.26 Impurities A1-3 216 1.43 239.6 0.264 Impurities A1-4 213.2 0.58 268.8 0.082
[0081] The results showed that ebiprazole starting material 1 and rela...
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