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High performance liquid chromatography method for separating and measuring oseltamivir phosphate and specific impurities of oseltamivir phosphate

A technology of high performance liquid chromatography and oseltamivir phosphate, which is applied in the field of analytical chemistry to achieve the effects of good reproducibility, simple and convenient method, and high sensitivity

Active Publication Date: 2019-04-05
HANGZHOU XINBOSI BIOMEDICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, there is currently no literature report that can completely separate oseltamivir phosphate impurities I, II, III, A, B, C, D, E, RRR isomers, RSS isomers, and RSR isomers simultaneously.

Method used

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  • High performance liquid chromatography method for separating and measuring oseltamivir phosphate and specific impurities of oseltamivir phosphate
  • High performance liquid chromatography method for separating and measuring oseltamivir phosphate and specific impurities of oseltamivir phosphate
  • High performance liquid chromatography method for separating and measuring oseltamivir phosphate and specific impurities of oseltamivir phosphate

Examples

Experimental program
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Effect test

example 1

[0037] The separation and determination of oseltamivir phosphate and its specific impurities in example 1 test sample

[0038] 1. Instruments and reagents:

[0039] Agilent 1260 liquid chromatograph equipped with G1314F ultraviolet detector and HPLC chromatographic workstation equipped with analytical instruments.

[0040] Acetonitrile (chromatographic grade), methanol (chromatographic grade), potassium dihydrogen phosphate (analytical grade), potassium hydroxide (analytical grade), phosphoric acid (analytical grade), purified water.

[0041] 2. Chromatographic conditions:

[0042] Chromatographic column: Octylsilane bonded silica gel liquid chromatography (4.6mm×250mm, 5μm)

[0043] Detection wavelength: 207nm;

[0044] Flow rate: 1.2ml / min;

[0045] Column temperature: 50°C;

[0046] Injection volume: 15μl;

[0047] Mobile phase: 0.05mol / L potassium dihydrogen phosphate buffer (adjust pH to 6.30 with 1mol / L potassium hydroxide)-methanol-acetonitrile (620:235:145)

[0...

Embodiment 2

[0068] Example 2: Methodological Validation

[0069] 1. Quantitation limit and detection limit

[0070] Precisely measure 1ml of each of the above (1)~(12) solutions, put them in the same 100ml measuring bottle, dilute to the mark with diluent, shake well, and use it as stock solution (A).

[0071] Detection limit solution: Accurately measure 1ml of the above stock solution (A), put it in a 50ml measuring bottle, dilute to the mark with a diluent, and shake well (equivalent to 0.02% of the concentration of the test solution).

[0072] Quantitation limit solution: Accurately measure 1ml of the above stock solution (A), put it in a 50ml measuring bottle, dilute to the mark with a diluent, and shake well (equivalent to 0.02% of the concentration of the test solution).

[0073] Precisely measure 15 μl each of the above-mentioned detection limit and quantification limit solutions, inject them into the liquid chromatograph, and record the chromatograms. The measurement results are ...

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Abstract

The invention relates to a high performance liquid chromatography method for separating and measuring oseltamivir phosphate and specific impurities of the oseltamivir phosphate. According to the highperformance liquid chromatography method for separating and measuring the oseltamivir phosphate and the specific impurities of the oseltamivir phosphate, octyl silane bonded silica gel columns are adopted, the mobile phase is 0.05 mol / L, the volume ratio of a monopotassium phosphate buffer solution to methyl alcohol to acetonitrile is 620 to 245 to 135, the column temperature is 48 DEG C-50 DEG C,the detection wave length is 207 nm, and the flow rate is 1.1-1.3 ml per minute; and three diastereoisomers of the oseltamivir phosphate, two isomerides (impurity C and impurity D), and a specific technology impurity A, a specific technology impurity B and a specific technology impurity C and the oseltamivir phosphate specific impurity I, the oseltamivir phosphate specific impurity II and the oseltamivir phosphate specific impurity III recorded in the 2015 version of 'Chinese Pharmacopoeia' can be separated totally at the same time by the high performance liquid chromatography method, the method is simple and exact, and is high in sensitivity, and is very important for the quality control over drug products.

Description

technical field [0001] The invention belongs to the field of analytical chemistry, and in particular relates to a high performance liquid chromatography method for separating and measuring oseltamivir phosphate and its specific impurities. Background technique [0002] Oseltamivir phosphate (seltamivir phosphate), chemical name: (R, 4R, 5S) 4-acetamido-5-amino-3(-propoxyethyl ester) 1-cyclohexane-1 carboxylate ethyl ester Phosphate, its chemical structure is: [0003] [0004] Oseltamivir phosphate, trade name Tamiflu (AMIFLU), is the antiviral compound that is successfully developed in 1996 by Gilead Sciences Inc. of the U.S. for preventing or treating bird flu. The drug has the characteristics of high efficiency, safety, and low drug resistance for the target treatment of influenza virus. It has been approved for marketing in many countries. It is currently the most effective anti-influenza virus drug and one of the most commonly prescribed drugs. [0005] The prepara...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/08
CPCG01N30/02G01N30/08
Inventor 沈欢金惠红王阿四刘阁刘艳华
Owner HANGZHOU XINBOSI BIOMEDICAL CO LTD
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