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Quantitative analysis method for escitalopram in human plasma

A quantitative analysis, human plasma technology, applied in the field of biological analysis, can solve the problems of large matrix interference, difficult to obtain samples, low analytes, etc., and achieve the effect of high degree of instrument automation, improved detection sensitivity, and high repeatability

Pending Publication Date: 2021-07-16
杭州百杏生物技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Biological samples of escitalopram have complex components, large matrix interference, and samples are difficult to obtain and the amount is small, and the concentration of analytes is usually very low. Establishment of a high-sensitivity and high-selectivity analytical method for the content of escitalopram

Method used

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  • Quantitative analysis method for escitalopram in human plasma
  • Quantitative analysis method for escitalopram in human plasma
  • Quantitative analysis method for escitalopram in human plasma

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] The preparation of embodiment 1 experimental solution and working solution

[0034] Mobile phase A: Measure about 500mL of ultrapure water into a 1L volumetric flask, add 1000μL of formic acid and 2000μL of 2.5M ammonium formate solution, dilute with ultrapure water to volume, ultrasonically degas, and set aside. Storage conditions: room temperature. Validity period: 2 days.

[0035] Mobile phase B: MS grade methanol solution. Storage conditions: room temperature. Validity period: 3 months.

[0036] Methanol: water (30:70, v:v) [denoted as diluent 1]: Add 300mL methanol and 700mL water into a glass bottle, shake and mix. Storage conditions: 4°C. Validity period: 3 months.

[0037] The stock solution of escitalopram was obtained by two independent weighings and prepared respectively. All prepared stock solutions should be stored in a refrigerator at 0-10°C. Before the long-term storage stability data of the stock solution is obtained, it is considered to be stabl...

Embodiment 2

[0055] A LC-MS / MS quantitative analysis method for escitalopram in human plasma, comprising the steps of:

[0056] (1) Preparation of standard working solution: the gradient concentrations of escitalopram working solution are 2.000, 10.00, 20.00, 80.00, 200.0, 300.0, 500.0ng·mL -1 , the concentration gradient of escitalopram quality control working solution is 2.000, 5.000, 100.0, 400.0ng·mL -1 ; The gradient concentrations of the standard curve are 0.1000, 1.000, 2.000, 8.000, 20.00, 30.00, 50.00ng·mL -1 , the concentrations of quality control samples were 0.2000, 0.5000, 10.00, 40.00ng·mL -1 ;

[0057] Internal standard working solution is 100.0ng·mL -1 ;

[0058] The preparation of the above solution only needs to ensure the final concentration, and its preparation method can be based on the preparation method of each solution in Example 1, or can be other methods.

[0059] (2) Sample processing: Using a pipette, add 100.0 μL of blank matrix (blank human plasma), water...

Embodiment 3

[0098] This example evaluates the intra-assay and inter-assay accuracy and precision of the LC-MS / MS method in Example 2 for determining the concentration of escitalopram in human plasma. According to the above method, the quality control samples of the above four concentrations of LLOQQC, LQC, MQC, and HQC were respectively prepared with 6 samples of each concentration, and the measurement of 6 samples of each concentration was repeated 3 times in three consecutive analysis batches. The calculation precision degree, the results are shown in the table below

[0099]

[0100]

[0101]

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Abstract

The invention provides a quantitative analysis method for escitalopram in human plasma by using a liquid chromatography-mass spectrometry (HPLC-MS / MS) technology. According to the method, the extraction recovery rate is increased, the matrix effect is reduced, the selectivity is enhanced, interference on analyte and internal standard quantitative analysis is reduced, and the detection sensitivity is improved.

Description

technical field [0001] The invention belongs to the field of biological analysis, and more specifically relates to a method for quantitatively analyzing escitalopram in human plasma by using liquid chromatography-mass spectrometry (HPLC-MS / MS). Background technique [0002] As a new type of antidepressant, escitalopram can effectively improve the curative effect of patients. Escitalopram has low health costs, low incidence of adverse reactions in cardiovascular system and liver function, good curative effect and few adverse reactions . [0003] In the consistency evaluation of generic drugs, how to determine better and more stable bioequivalence evaluation, the detection and analysis of drugs is very important. Biological samples of escitalopram have complex components, large matrix interference, and samples are difficult to obtain and the amount is small, and the concentration of analytes is usually very low. To establish a highly sensitive and highly selective method for...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/06G01N30/88
CPCG01N30/06G01N30/88
Inventor 楼金芳曲双乐艳汤吕莎沈卓凡
Owner 杭州百杏生物技术有限公司
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