HPLC (high-performance liquid chromatography) detection method for escitalopram oxalate related substances

A technology of escitalopram oxalate and high performance liquid phase, applied in the field of analytical chemistry, can solve problems such as inability to separate, and achieve the effects of high sensitivity and accuracy, strong specificity and good linear relationship

Active Publication Date: 2017-01-11
山东锐顺药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] At present, escitalopram oxalate has been recorded in USP and EP, but not yet recorded in Chinese Pharmacopoeia
And in USP test conditions: mobile phase A is potassium dihydrogen phosphate of 3.4g / ml adjusted to pH3.0 with phosphoric acid or sodium hydroxide, mobile phase B is acetonitrile: mobile phase A=10:90, mobile phase C is acetonitrile : Under the condition of mobile phase A=65:35, the peaks of escitalopram oxalate impurities (impurity C and impurity L, impurity B and impurity M) overlap and cannot be separated

Method used

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  • HPLC (high-performance liquid chromatography) detection method for escitalopram oxalate related substances
  • HPLC (high-performance liquid chromatography) detection method for escitalopram oxalate related substances
  • HPLC (high-performance liquid chromatography) detection method for escitalopram oxalate related substances

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Experimental program
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Effect test

Embodiment 1

[0025] 1. Instruments and reagents

[0026] Instrument: Shimadzu liquid chromatograph, LC-20AT pump, M20A diode array detector, LC solution workstation

[0027] Reagents: acetonitrile (chromatographically pure); potassium dihydrogen phosphate, phosphoric acid, triethylamine (analytical pure)

[0028] 2. Method establishment

[0029] (1) Wavelength selection: Escitalopram oxalate and its impurities have their own characteristics in absorbing ultraviolet light. Select the absorption spectrum under the specificity item, escitalopram oxalate and its impurities all have strong ultraviolet absorption at the wavelength of 237nm, so 237nm is selected as the detection wavelength of this product.

[0030] (2) Interference test

[0031] A mixed solution of escitalopram oxalate and each known impurity was prepared, and the impurities were located separately, so as to judge whether the blank solvent and each impurity interfered with the detection.

[0032] experiment method:

[0033] ...

Embodiment 2

[0083] Determination of impurities in escitalopram oxalate: use octadecylsilane bonded silica gel as a filler, dissolve and dilute to the mark with phosphate buffer (3.4g / L potassium dihydrogen phosphate, add 5ml triethylamine, Use phosphoric acid to adjust the pH to 3.5) as mobile phase A; mobile phase A-acetonitrile solution=8:2 as mobile phase B; mobile phase A-acetonitrile solution=7:13 as mobile phase C, and perform gradient elution according to the table below.

[0084]

[0085]

[0086] The detection wavelength is 237nm, column temperature: 30°C, the separation degree of the main peak and miscellaneous peaks should meet the requirements

[0087] Preparation of escitalopram oxalate test solution: get an appropriate amount of escitalopram oxalate sample (about 0.5 mg / ml of escitalopram oxalate)

[0088] Determination method: under the chromatographic conditions of the present invention, get each 20 μ l of need testing solution, inject liquid chromatograph, record ch...

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Abstract

The invention belongs to the field of pharmaceutical analysis and particularly relates to a HPLC (high-performance liquid chromatography) detection method for escitalopram oxalate related substances. The escitalopram oxalate related substances are determined with HPLC, a C18 column is taken as a chromatographic column, a phosphate buffer solution is taken as a mobile phase A, the mobile phase A and an acetonitrile solution are mixed in a certain ratio to form a mobile phase B, the mobile phase A and the acetonitrile solution are mixed in a certain ratio to form a mobile phase C, and the escitalopram oxalate related substances are detected with a gradient elution method. The method can separate impurities, is high in specificity and sensitivity and good in repeatability and durability, can well control known impurities and unknown impurities of escitalopram oxalate and guarantees safety of escitalopram oxalate.

Description

technical field [0001] The invention belongs to the field of analytical chemistry, and in particular relates to a high-efficiency liquid phase determination method for related substances of escitalopram oxalate. Background technique [0002] Escitalopram oxalate has the effect of enhancing the 5-hydroxytryptamine (5-HT) energy of the central nervous system, belongs to the selective 5-hydroxytryptamine reuptake inhibitor, and is clinically used for the treatment of severe depression and generalized anxiety disorder. However, there are a variety of related substances in escitalopram oxalate: impurities A~E, H~M. The existence of these impurities seriously affects the quality control and drug safety of escitalopram oxalate. The relevant substances of citalopram were detected and monitored. [0003] See Table 1 for the codes and names of related substances of escitalopram oxalate. [0004] Table 1 Codes and names of related substances of escitalopram oxalate [0005] [00...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/34G01N30/74G01N30/02
CPCG01N30/02G01N30/34G01N30/74G01N2030/067
Inventor 马春丽刘云雷邢晓燕冯永斌
Owner 山东锐顺药业有限公司
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