A kind of detection method of pimavanserin tartrate

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

Active Publication Date: 2021-02-09
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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  • A kind of detection method of pimavanserin tartrate
  • A kind of detection method of pimavanserin tartrate
  • A kind of detection method of pimavanserin tartrate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038]Purity test of pimofanserin tartrate:

[0039]1) Prepare test sample solution:

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

[0041]2) High performance liquid chromatography determination: determination conditions: Gensial CN 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 the gradient elution time and the volume ratio of mobile phase acetonitrile is: 0~7min 45% run, 7~12min run from 45%~30%, 12~20min run from 30%~70%, 20 ~30min 70% operation; flow rate is 1.0mL / min; column temperature is 25℃; UV detector detection wavelength is 215nm; injection volume is 10μL, record chromatogram, seefigure 1 ;

[0042]byfigure 1 It can be seen that the high performance liquid chromatogram of pimofanserin tartrate has good peak shape and high peak puri...

Embodiment 2

[0044]System adaptability study of pimofenserin pimobendan tartrate:

[0045]1) Prepare test sample solution:

[0046]Accurately weigh 24.98 mg of pimovanserin tartrate standard substance in a 20mL volumetric flask, add diluent to dissolve and dilute to the mark, and mix well to obtain a test sample solution with a concentration of pimovanserin tartrate of 1.2440 mg / mL ;

[0047]2) High performance liquid chromatography determination: the determination conditions are: Gensial CN 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 45%~30%, 12~20min 30%~70%, 20 ~30min 70% operation; flow rate is 1.0mL / min; column temperature is 25℃; UV detector detection wavelength is 215nm; injection volume is 10μL, record chromatogram (seefigure 2 ), continuous measurement 6 times, the results are sh...

Embodiment 3

[0052]Investigation on the specificity of pimophanserin tartrate:

[0053]1) Preparation of impurity stock solution: Weigh impurity A 5.12mg, impurity B 5.17mg, impurity C 5.23mg, impurity D 5.16mg, impurity E 5.19mg into a 20mL volumetric flask, add diluent to dissolve and dilute to the mark, mix Evenly, as an impurity stock solution for later use;

[0054]Among them, 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) Preparation of resolution solution: Weigh 25.04 mg of pimovanserin tartrate standard into a 20 mL volumetric flask, and add 1 mL of each of the above impurity stock solutions, dissolve and dilute to the mark with a diluent, and mix, as the resolution Solution (wherein, the concentration of pimofenserin tartrate standard solution in the solution is: 1.2520mg / mL, the concentrat...

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Abstract

The invention discloses a method for detecting pimavanserin tartrate. The method comprises the following steps: 1) preparing a standard reference substance solution of pimavanserin tartrate; 2) preparing a test sample solution; 3) using reverse-phase high performance liquid chromatography to measure pimavanserin tartrate in the standard reference substance solution The reversed-phase high-performance liquid chromatogram, make the degree of separation ≥ 1.5 between pimavanserin tartrate and its adjacent impurities; 4) use reversed-phase high-performance liquid chromatography to measure the chromatogram of test sample solution; 5) utilize external standard method to determine the content of pimavanserin tartrate in the test sample solution. The method can effectively measure the content of pimavanserin tartrate, and the detection has no interference, good specificity, high sensitivity, good stability, high precision and reliable method (the recovery rate of pimavanserin tartrate is greater than 90%) , while the operation is relatively simple, which provides a guarantee for the quality of subsequent pimavanserin tartrate raw materials and preparations.

Description

Technical field[0001]The invention belongs to the field of drug analysis, and in particular relates to a detection method of pimofenserin tartrate.Background technique[0002]Pimavanserin tartrate, English name Pimavanserin (INN) or pimavanserin tartate (USAN), sold under the trade name Nuplazid, was developed by Acadia Pharmaceuticals for the treatment of Parkinson's disease, psychosis and schizophrenia Non-dopaminergic atypical antipsychotics for symptomatic diseases. Compared with other antipsychotics, pimofenserin tartrate has a unique mechanism of action, which is a selective inverse agonist of serotonin 5-HT2A receptor, and the selectivity of this site for 5-HT2C receptor is 40 times, no significant affinity or activity on serotonin. The drug has reached the expectations of the Phase III clinical trial for the treatment of Parkinson's disease and psychosis, and has completed the Phase II clinical trial for adjuvant treatment of schizophrenia and antipsychotic treatment.[0003]Pim...

Claims

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Application Information

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Patent Type & Authority Patents(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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