Method for determining impurities in timolol maleate
A technology of timolol maleate and maleic acid, which is applied in the field of determination of impurities in timolol maleate, can solve the problems of large damage to the chromatographic column, incapable of qualitative analysis, limited popularity, etc., and achieve high accuracy High, improve economy and popularization, and highly targeted effect
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Embodiment 1
[0078] A method for measuring impurities in timolol maleate, comprising the following steps:
[0079] Take 50 mg of timolol maleate, add 1 ml of 5M sodium hydroxide solution, heat in a water bath at 75°C for 30 min, cool, add 1 ml of 5M hydrochloric acid solution, add solvent (0.01M ammonium acetate aqueous solution containing 0.2% formic acid-methanol=50 : 50) diluted to 10ml, must destroy solution I;
[0080] Take 10 mg of timolol maleate and 200 mg of maleic acid, thoroughly grind and mix them evenly under the condition of avoiding light, heat in an oven at 105°C for 60 min, cool down, take 10 mg with a solvent (0.01M ammonium acetate aqueous solution containing 0.2% formic acid -Methanol=50:50) was diluted to 10ml to obtain Destruction Solution II;
[0081] Take timolol maleate, add potassium tert-butoxide in tert-butanol solution, place in 26°C water bath for 30 minutes, add solvent (0.01M ammonium acetate aqueous solution containing 0.2% formic acid-methanol=50:50) and ...
Embodiment 2
[0111] A method for measuring impurities in timalol maleate, comprising the following steps:
[0112] Wherein, the preparation method of preparing destruction solution I, destruction solution II, destruction solution III, destruction solution IV and system suitability solution is the same as that in Example 1;
[0113] The above destruction solutions I~IV and the system suitability solution, impurities B, C, D, E, F control solution (USP, batch numbers are R073G0, R090T0, R071X0, R073H0 and R102U0) respectively by quadrupole-electrostatic field track The trap was detected by a high-resolution mass spectrometer (thermo Q Exactive), the chromatographic column was ACE Excel3 C18-AR (3 μm, 150×4.6 mm), the mobile phase conditions were the same as in Example 1, and the detector was a UV-high-resolution mass spectrometry detector.
[0114] The ESI source, ion source parameters and scanning parameters are shown in Table 4. The structural formula of each impurity is shown in Example ...
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