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Detection method for determining polymer impurities in mezlocillin sodium

A mezlocillin sodium and detection method technology, which is applied in the detection field of polymer impurities in mezlocillin sodium, can solve the problems of accurate qualitative and quantitative testing of impurities, long separation time, cumbersome operation, etc., and achieve accurate and fast qualitative Quantitative analysis, shortened separation time, and high resolution effects

Inactive Publication Date: 2013-04-24
SEPAX TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

When the traditional glass gel chromatographic column (Sephadex G-10) is used to separate polymer impurities in mezlocillin sodium, the column efficiency is relatively low, and the general column efficiency is only 400~1000; The operation is cumbersome, the separation time is long, and the separation degree is poor, which brings a lot of inconvenience to the accurate qualitative and quantitative testing of impurities.

Method used

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  • Detection method for determining polymer impurities in mezlocillin sodium
  • Detection method for determining polymer impurities in mezlocillin sodium
  • Detection method for determining polymer impurities in mezlocillin sodium

Examples

Experimental program
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Effect test

Embodiment 1

[0045] First, take an appropriate amount of mezlocillin sodium sample and dissolve it completely in water to prepare a sample solution to be tested with a concentration of 10 mg / L. The sample solution was filtered through a microporous membrane with a pore size of 0.45um and set aside.

[0046] A liquid chromatographic column filled with a size-exclusion chromatography filler of SEPAX company model SRT-C, the filler has a particle size of 5 microns and a pore size of 100 Å. The column has a diameter of 7.8 mm and a length of 300 mm.

[0047]The chromatographic conditions used are: 50mmol phosphate buffer solution as mobile phase, pH value is 8.0; flow rate is 0.5mL / min; detection wavelength of ultraviolet detector is 254nm; injection volume is 20uL; injection concentration is 10mg / mL ; The column temperature is 20°C.

[0048] According to above-mentioned chromatographic condition, carry out high performance liquid chromatography detection, detection result is as follows f...

Embodiment 2

[0050] First, take an appropriate amount of mezlocillin sodium sample and dissolve it completely in water to prepare a sample solution to be tested with a concentration of 10 mg / L. The sample solution was filtered through a microporous membrane with a pore size of 0.45um and set aside.

[0051] A liquid chromatographic column filled with a size-exclusion chromatography filler of SEPAX company model SRT-C, the filler has a particle size of 5 microns and a pore size of 100 Å. The inner diameter of the chromatographic column is 7.8 mm, and the inner length of the column is 300 mm.

[0052] The chromatographic conditions adopted are: 25mmol of phosphate buffer solution as mobile phase, pH value of 7.0; flow rate of 1.0mL / min; ultraviolet detection wavelength of 230nm; injection volume: 10uL; 25°C.

[0053] According to above-mentioned chromatographic condition, carry out high performance liquid chromatography detection, detection result is as follows image 3 with Figure 4 s...

Embodiment 3

[0055] First take an appropriate amount of mezlocillin sodium sample and dissolve it completely in water to prepare a sample solution to be tested with a concentration of 5 mg / L. The sample solution was filtered through a microporous membrane with a pore size of 0.22um and set aside.

[0056] A liquid chromatographic column filled with a size-exclusion chromatography filler of SEPAX company model SRT-C, the filler has a particle size of 5 microns and a pore size of 100 Å. The inner diameter of the chromatographic column is 7.8 mm, and the inner length of the column is 300 mm.

[0057] The chromatographic conditions adopted are: 50mmol of phosphate buffer solution as mobile phase, pH value of 7.0; flow rate of 1.0mL / min; ultraviolet detection wavelength of 254nm; injection volume: 20uL; 30°C.

[0058] According to above-mentioned chromatographic condition, carry out high performance liquid chromatography detection, detection result is as follows Figure 5 and Image 6 show...

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Abstract

The invention provides a detection method for determining polymer impurities in mezlocillin sodium. The detection method employs a high performance liquid chromatography size exclusion chromatography. The chromatography conditions are as follows: a chromatographic column employs hydrophilic silica for globular protein as a stationary phase and 50 mmol of a phosphate buffered solution as a mobile phase; a flow velocity of the mobile phase is 0.5-2.0 mL / min; a detection wavelength is 230-254 nm; a column temperature is a room temperature; a sample volume is 10-80 [mu]L; granularity of the chromatographic column stationary phase is 5 [mu]m, aperture of the chromatographic column stationary phase is 10 nm; the inner diameter of the chromatographic column is 7.8 mm; and the column length is 300 mm. he detection method can perform rapidly qualitative and quantitative determination on the polymer impurities in mezlocillin sodium, simultaneously simplifies operation steps, increases detection precision and shortens detection time.

Description

technical field [0001] The invention relates to the field of size exclusion detection, in particular to a detection method for measuring polymer impurities in mezlocillin sodium. Background technique [0002] Mezlocillin sodium is a semi-synthetic penicillin antibiotic, which has a strong antibacterial effect on Gram-positive bacteria such as Escherichia coli, Enterobacter, and Proteus. Mezlocillin is a penicillin derivative administered parenterally and has bactericidal effect in large doses. The antibacterial spectrum of mezlocillin sodium is basically the same as that of ampicillin and carbenicillin. However, there are some polymer allergic impurities in mezlocillin sodium. Therefore, it is necessary to control the total amount of high molecular impurities in the quality standard of the drug. [0003] At present, the 2010 edition of "Chinese Pharmacopoeia" uses medium and low pressure liquid chromatography detection method for the detection of polymer impurities in me...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/60
Inventor 龚立冬崔爱艳李彧娜
Owner SEPAX TECH
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