Analytic method of omeprazole related substance

An analysis method and related substance technology, applied in the analysis of materials, material separation, instruments, etc., can solve the problems of low sensitivity, less detected impurities, harsh chromatographic conditions, etc., and achieve the effect of high sensitivity, effective method and high sensitivity

Active Publication Date: 2014-02-19
CSPC OUYI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0003] So far, the standards included in the British Pharmacopoeia and the Chinese Pharmacopoeia have shortcomings such as overlapping solvent peaks and impurity peaks, low sensitivity, and few detected i

Method used

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  • Analytic method of omeprazole related substance
  • Analytic method of omeprazole related substance
  • Analytic method of omeprazole related substance

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Example 1 High performance liquid chromatography analysis of omeprazole and several impurities

[0022] Several related substances are: A, D, E, C, I, F.

[0023] Instruments and analysis conditions - Agilent 1100, chromatographic workstation, automatic sampler, column oven. The chromatographic column is Agilent XDB-C18 (4.6mm*150mm, 5um), the detection wavelength is 280 nm, the flow rate is 1.0 ml / min, the column temperature is 30 ℃, the organic phase is acetonitrile, and the aqueous phase is phosphate buffer with pH 7.6 , the gradient elution method is:

[0024]

[0025] Experimental steps:

[0026] Accurately weigh an appropriate amount of omeprazole and several impurities (A, C, D, E, I), dissolve them with a diluent and constant volume, and make a mixed solution containing omeprazole and related impurities as the test solution . Perform high-performance liquid phase analysis according to the above conditions, inject 20 ul, see the attached manual for ...

Embodiment 2

[0028] Embodiment two Methodological investigation of the analytical method of the present invention

[0029] Examination of specificity: other excipients without omeprazole were prepared for destruction, and the excipients did not interfere with the determination of omeprazole-related substances, which proved that their specificity was good.

Embodiment

[0030] Embodiment Analytical method Stability test

[0031] In order to better examine the specificity and stability of this method, acid, alkali, oxidation and water damage tests were designed.

[0032] Instruments and analysis conditions - Water 2695 chromatographic workstation, automatic sampler, column thermostat. The chromatographic column is Agilent XDB-C18 (4.6mm*150mm, 5um), the detection wavelength is 280nm, the flow rate is 1.0ml / min, the column temperature is 30 ℃, the organic phase is acetonitrile, and the aqueous phase is phosphate buffer with pH7.6 , the gradient elution method is:

[0033]

[0034] Acid destruction test: Weigh 20mg of omeprazole sample into a 100ml volumetric flask, add 5ml of 0.1mol / L hydrochloric acid solution, let it destroy for 2min, add 0.1mol / L NaOH solution to neutralize, dilute to volume with diluent, shake well, After centrifugation, inject into the liquid chromatograph, inject 20ul of the sample, record the chromatogram, see...

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Abstract

The invention provides an analytic method of an omeprazole related substance. The analytic method is characterized in that high performance liquid chromatography is adopted, an organic solvent and salt mixed phase is used for dissolving a sample, acetonitrile and phosphate with the pH of 7.6 are used as mobile phases, and the gradient elution is carried out on octyl bonds and a silica gel chromatographic column. The analytic method can be used for simply and effectively solving the defects of incapability of separating the rated substance and solvent peaks, little detection amount of impurities and the like and efficiently separating and identifying related impurities of the omeprazole.

Description

technical field [0001] The invention relates to a method for analyzing related substances of omeprazole, in particular to a method for separating and quantitatively determining related substances of omeprazole by high performance liquid chromatography. Background technique [0002] The so-called "related substances (relatedSubstances)" in drug analysis refers to substances that are not the main components in a specific drug, but are related to the ingredients. Since a drug has to go through a relatively complicated and lengthy process from the synthesis of raw materials to the preparation of related preparations, storage, transportation and use, during this period, each process may produce related substances, such as production Starting materials, reagents, intermediates, by-products and isomers may be brought in; during storage and transportation, special impurities such as degradation products, polymers or crystal transformations may be produced. In order to ensure the sa...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 郭文建王金虎孙玲
Owner CSPC OUYI PHARM CO LTD
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