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Method for measuring impurity content of faropenem polymers in faropenem sodium raw materials and preparations

A technology of faropenem sodium and polymers, applied in the field of pharmaceutical analysis, to achieve the effect of ensuring product quality, good repeatability, and improving safety

Active Publication Date: 2010-10-06
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there is no report on the specific determination method of faropenem polymer, so the establishment of a method for the determination of faropenem polymer is of great significance for the quality control and safe use of carbapenem antibiotics

Method used

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  • Method for measuring impurity content of faropenem polymers in faropenem sodium raw materials and preparations
  • Method for measuring impurity content of faropenem polymers in faropenem sodium raw materials and preparations

Examples

Experimental program
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Embodiment 1

[0030] Example 1: Determination of Faropenem Polymer Content in Faropenem Sodium Raw Materials and Its Preparations by Standard Curve Method

[0031] 1. Chromatographic conditions

[0032] Instrument: American Agilent 1100 series high performance liquid chromatography;

[0033] Gel chromatography column: Sephadex G-10, 15.0mm×400mm;

[0034] Mobile Phase: Mobile Phase A: NaH 2 PO 4 1.08g and Na 2 HPO 4 4.38g to 1000ml water, with H 3 PO 4 Adjust the pH to 7.0;

[0035] Mobile Phase B: 0.01% Sodium Lauryl Sulfate

[0036] Flow rate: 1.0ml / min

[0037] Column temperature: room temperature;

[0038] Wavelength: 254nm

[0039] 2. Experimental steps:

[0040] 1. Make a standard curve:

[0041] ① Put 62.5mg of faropenem reference substance in a 50ml volumetric flask, dilute it with water to 0.05, 0.10, 0.15, 0.20, 0.25, 0.30 and 0.4mg / ml solutions, and shake well;

[0042] ②Take 20ul of the reference substance solution at each dilution point and pass through the gel colu...

Embodiment 2

[0049] Example 2: Determination of Faropenem Polymer Content in Faropenem Sodium Raw Materials and Its Preparations by Standard Curve Method

[0050] 1. Chromatographic conditions

[0051] Same as Example 1

[0052] 2. Experimental steps:

[0053] 1. Make a standard curve:

[0054] ① Put 62.5mg of faropenem reference substance in a 50ml volumetric flask, dilute it with water to 0.05, 0.10, 0.15, 0.20, 0.25, 0.30 and 0.4mg / ml solutions, and shake well;

[0055] ②Take 20ul of the reference substance solution at each dilution point and pass through the gel column in turn, use mobile phase B as the mobile phase, detect at a wavelength of 254nm, record the chromatogram, obtain the retained peak area, and compare the peak area (A) with the concentration (C) Perform linear regression to obtain the standard curve and linear equation, and calculate the regression coefficient;

[0056] ③The regression equation obtained through calculation is: C=57203A+76.287R 2 =0.9999

[0057] 3....

Embodiment 3

[0063] Example 3: Determination of Faropenem Polymer Content in Faropenem Sodium Raw Materials and Its Preparations by Standard Curve Method

[0064] 1. Chromatographic conditions

[0065] Instrument: American Agilent 1100 series high performance liquid chromatography;

[0066] Gel chromatography column: Sephadex G-10, 15.0mm×400mm;

[0067] Mobile phase: mobile phase A: take NH 4 Cl 0.54g to 1000ml water, adjust pH to 7.0 with NaOH

[0068] Mobile Phase B: 0.01% Sodium Lauryl Sulfate

[0069] Flow rate: 1.0ml / min

[0070] Column temperature: room temperature;

[0071] Wavelength: 254nm

[0072] Two, experimental procedure is with embodiment 1

[0073] 3. Results

[0074] According to the standard curve method, the content of ropenem polymer was calculated as 0.25%. The RSD value is 0.06%.

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Abstract

The invention particularly relates to a method for measuring the content of faropenem polymers in faropenem sodium raw materials and preparations by high-efficiency liquid chromatography, which belongs to the field of medicine analysis. The measuring method of the invention is gel chromatography. The high-efficiency liquid chromatogram is used for detection, and the chromatogram conditions are as follows: (1) the gel permeation chromatography has the exclusion molecular weight between 600 and 800 Daltons; (2) the mobile phases as two mobile phases, wherein the mobile phase A is a water phase solution with the pH value between 5.0 and 8.5 and the concentration between 0.01 and 0.2 mol / L, and the mobile phase B is water or a sodium dodecyl sulfate water solution or a glycin solution between 0.005 and 0.02 percent; (3) the column temperature is the room temperature; (4) the flowing rate is between 0.5 and 1.0 ml / min; and (5) the detection wavelength is between 210 and 300 nm. The method of the invention has the advantages of strong specificity, good repetitiveness and high automation degree, and the polymers in the faropenem sodium raw materials and the preparations can be accurately qualified.

Description

technical field [0001] The invention belongs to the field of drug analysis, and in particular relates to a method for determining faropenem polymer content in faropenem sodium raw materials and preparations thereof by high performance liquid chromatography. Background technique [0002] Faropenem is an atypical β-lactam antibiotic that is a derivative of penems. Two types of compounds, carbapenems and penems, have attracted great interest, and penems have more unique advantages. Currently, five penem derivatives are under development, and faropenem is convenient. is one of them. In addition to being weak against Pseudomonas aeruginosa, it has a broad antibacterial spectrum and is particularly effective against anaerobic bacteria, which is better than carbapenem antibiotics. It shows broad-spectrum antibacterial activity against aerobic and anaerobic Gram-positive bacteria and Gram-negative bacteria, especially against drug-resistant Staphylococcus, Enterococcus and other G...

Claims

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Application Information

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IPC IPC(8): G01N30/02C07D499/893A61K31/431
Inventor 赵志全
Owner LUNAN PHARMA GROUP CORPORATION
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