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Detection method of pimavanserin tartrate

A technology of pimavanserin and detection method, which is applied in the field of drug analysis and achieves the effects of reliable method, high precision and good stability

Active Publication Date: 2019-04-12
LIVZON NEW NORTH RIVER PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There is no patent literature report about the detection method of pimavanserin tartrate at present, therefore, it is particularly important and urgent for pharmaceutical manufacturers to provide a detection method for the content of pimavanserin tartrate

Method used

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  • Detection method of pimavanserin tartrate
  • Detection method of pimavanserin tartrate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Pimavanserin tartrate purity test:

[0039] 1) Prepare the test sample solution:

[0040] Accurate 25mg of pimavanserin tartrate standard substance, in a 20mL volumetric flask, add an appropriate amount of diluent to dissolve and dilute to the mark, mix well, and use it as the test sample solution;

[0041] 2) High performance liquid chromatography determination: determination conditions are: Gensial CN chromatographic column: 4.6mm×250mm, 5μm; mobile phase is acetonitrile: potassium dihydrogen phosphate solution = (45~70): (55~30) (v / v ) for gradient elution, the order of gradient elution time and the volume ratio of mobile phase acetonitrile is: 0-7min 45% operation, 7-12min from 45%-30% operation, 12-20min from 30%-70% operation, 20 ~30min 70% operation; flow rate is 1.0mL / min; column temperature is 25°C; UV detector detection wavelength is 215nm; injection volume is 10μL, record the chromatogram, see figure 1 ;

[0042] Depend on figure 1 It can be seen that the...

Embodiment 2

[0044] Pimavanserin tartrate system adaptability study:

[0045] 1) Prepare the test sample solution:

[0046] Accurately take by weighing pimavanserin tartrate standard substance 24.98mg in the 20mL volumetric flask, add diluent to dissolve and dilute to the mark, mix, and the concentration of pimavanserin tartrate is 1.2440mg / mL for the test sample solution ;

[0047] 2) High-performance liquid chromatography measurement: The measurement conditions are: Gensial CN chromatographic column: 4.6mm×250mm, 5μm; mobile phase is acetonitrile: potassium dihydrogen phosphate solution = (45:70) ~ (55:30) (v / v ) for gradient elution, the order of gradient elution time and the volume ratio of mobile phase acetonitrile is: 0-7min 45% operation, 7-12min from 45%-30% operation, 12-20min from 30%-70% operation, 20 ~30min 70% operation; flow rate is 1.0mL / min; column temperature is 25°C; UV detector detection wavelength is 215nm; injection volume is 10μL, record the chromatogram (see figu...

Embodiment 3

[0052] Investigation on the specificity of pimavanserin tartrate:

[0053] 1) Preparation of impurity stock solution: Weigh 5.12 mg of impurity A, 5.17 mg of impurity B, 5.23 mg of impurity C, 5.16 mg of impurity D, and 5.19 mg of impurity E in a 20mL volumetric flask, add diluent to dissolve and dilute to the mark, mix Uniform, as impurity stock solution stand-by;

[0054]Wherein impurity A is 4-isobutoxybenzonitrile, impurity B is 4-isobutoxybenzylamine, impurity C is 4-(4-fluorobenzylamino)-1-methylpiperidine, and impurity D is 1,3-bis(4-isobutoxybenzyl)urea, impurity E is 1-(4-fluorobenzyl)-3-(4-isobutoxybenzyl)urea;

[0055] 2) Resolution solution preparation: Weigh 25.04 mg of pimavanserin tartrate standard substance into a 20 mL volumetric flask, add 1 mL each of the above-mentioned impurity stock solution, dissolve with diluent and dilute to the mark, mix well, and use it as the resolution Solution (wherein, the pimavanserin tartrate standard solution concentration i...

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Abstract

The invention discloses a detection method of pimavanserin tartrate. The detection method comprises the following steps that (1) a standard reference solution of the pimavanserin tartrate is prepared;(2) a sample solution for test is prepared; (3) a reversed-phase high performance liquid chromatography chromatogram of the pimavanserin tartrate in the standard reference solution is measured by using a reversed-phase high performance liquid chromatography, and degree of separation between the pimavanserin tartrate and impurities adjacent to the pimavanserin tartrate is enabled to be greater than or equal to 1.5; (4) a chromatogram of the sample solution for test is measured by using the reversed-phase high performance liquid chromatography; and (5) the content of the pimavanserin tartrate in the sample solution for test is determined by using an external standard method. According to the detection method of the pimavanserin tartrate, the content of the pimavanserin tartrate can be measured effectively, and no interference exists in the detection, the specialization is good, the sensibility is high, the stability is good, the degree of precision is high and the method is reliable (the recovery ratio of the pimavanserin tartrate is greater than 90%); and meanwhile, the operation is relatively simple, and the quality of subsequent pimavanserin tartrate bulk pharmaceutical chemicalsand preparations is guaranteed.

Description

technical field [0001] The invention belongs to the field of drug analysis, in particular to a detection method for pimavanserin tartrate. Background technique [0002] Pimavanserin tartrate, English name Pimavanserin (INN) or pimavanserin tartate (USAN), sold under the trade name Nuplazid, is developed by Acadia Pharmaceuticals in the United States for the treatment of Parkinson's disease psychosis and schizophrenia non-dopaminergic atypical antipsychotics. Compared with other antipsychotic drugs, pimavanserin tartrate has a unique mechanism of action, which is a selective inverse agonist of 5-hydroxytryptamine 5-HT2A receptors, and the selectivity of this site for 5-HT2C receptors is 40-fold, with no significant affinity or activity on serotonin. The drug has met the expectations of Phase III clinical trials for the treatment of Parkinson's disease psychosis, and has completed Phase II clinical trials for adjuvant treatment of schizophrenia and antipsychotic drug treatme...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/89
CPCG01N30/89
Inventor 陈月嫦谢伟健姜桥王标李冰冰王龙书
Owner LIVZON NEW NORTH RIVER PHARMA
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