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Removing method of polymer impurities in piperacillin sodium and tazobactam sodium for injection

A technology of piperacillin sodium and tazobactam sodium, which is applied to the active ingredients of heterocyclic compounds, drug delivery, pharmaceutical formulations, etc., which can solve problems such as interference, impact on polymer impurity analysis, and poor separation effect, so as to ensure safety sexual effect

Inactive Publication Date: 2020-08-11
JIANGSU HAIHONG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the methods for polymer impurities in piperacillin sodium and tazobactam sodium for injection mainly include Sephadex G10 chromatography (SephadexG10 chromatography) and high performance gel chromatography (HPSEC method), but the SephadexG10 chromatography system Low column efficiency and poor separation effect; although the HPSEC method has good separation ability for polymer impurities, it is easily interfered by other polar impurities in the drug, which affects the analysis of polymer impurities

Method used

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Examples

Experimental program
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Effect test

Embodiment 1

[0022] This embodiment is a method for removing polymer impurities in piperacillin sodium and tazobactam sodium for injection.

[0023] Add piperacillin sodium-tazobactam sodium freeze-dried agent for injection into purified water for forced degradation to form a forced degradation solution for piperacillin sodium-tazobactam sodium. After standing for 3 days, add it to a high-efficiency gel chromatography column, Pass through the mobile phase for gradient elution. The high-efficiency gel chromatographic column described in this example is CAPCELL-MGII-C18, with a size of 4.6 mm×25 mm and a filter pore size of 5 μm. The mobile phase is sodium dihydrogen phosphate buffer or methanol solution. Wherein, the concentration of the sodium dihydrogen phosphate buffer solution is 3.12g / L, and its pH is 3.5. The time for gradient elution and the mobile phase ratio are: 1min, 90%→85%; 5min, 85%→65%; 10min, 65%→55%; 35min, 55%→35%; 60min, 35%→ 15%; 85min, 15%→90%; 86min, 90%. In this e...

Embodiment 2

[0025] This embodiment is also a method for removing polymer impurities in piperacillin sodium and tazobactam sodium for injection. Add piperacillin sodium-tazobactam sodium freeze-dried agent for injection into purified water for forced degradation to form a piperacillin sodium-tazobactam sodium forced degradation solution, place it for 18 days, add it to a high-efficiency gel chromatography column, Pass through the mobile phase for gradient elution. The high-efficiency gel chromatographic column described in this example is CAPCELL-MGII-C18, with a size of 4.6 mm×25 mm and a filter pore size of 5 μm. The mobile phase is sodium dihydrogen phosphate buffer or methanol solution. Wherein, the concentration of the sodium dihydrogen phosphate buffer solution is 3.12g / L, and its pH is 3.5. The time for gradient elution and the mobile phase ratio are: 3min, 90%→85%; 8min, 85%→65%; 22min, 65%→55%; 50min, 55%→35%; 70min, 35%→ 15%; 85.5min, 15%→90%; 95min, 90%. In this embodiment, ...

Embodiment 3

[0027] This embodiment is also a method for removing polymer impurities in piperacillin sodium and tazobactam sodium for injection. Add the piperacillin sodium-tazobactam sodium lyophilized agent for injection into purified water for forced degradation to form a piperacillin sodium-tazobactam sodium forced degradation solution, which is placed for 30 days; then the prepared piperacillin sodium-tazobactam The forced degradation solution of sodium tannium is added to the high-efficiency gel chromatography column, and the mobile phase is passed through for gradient elution. The high-efficiency gel chromatographic column described in this example is CAPCELL-MGII-C18, with a size of 4.6 mm×25 mm and a filter pore size of 5 μm. The mobile phase is sodium dihydrogen phosphate buffer or methanol solution. Wherein, the concentration of the sodium dihydrogen phosphate buffer solution is 3.12g / L, and its pH is 3.5. The time for gradient elution and the mobile phase ratio are: 5min, 90%...

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Abstract

The invention discloses a removing method of polymer impurities in piperacillin sodium and tazobactam sodium for injection. The removing method comprises the steps of adding a piperacillin sodium andtazobactam sodium freeze-drying agent for injection to a solvent for mandatory degradation to obtain a piperacillin sodium and tazobactam sodium mandatory degradation solution, performing placing fordefinite time, adding the piperacillin sodium and tazobactam sodium mandatory degradation solution after placing for definite time in an efficient gel chromatographic column, charging a mobile phase,and performing gradient elution. Through controlling the concentration of an eluent, column temperature, elution time and the proportion of the mobile phase, the polymer impurities in piperacillin sodium and tazobactam sodium for injection are removed, the polymer impurities in piperacillin sodium and tazobactam sodium are effectively controlled, and the safety of the piperacillin sodium and tazobactam sodium for injection is guaranteed.

Description

technical field [0001] The invention relates to a method for removing polymer impurities in piperacillin sodium and tazobactam sodium for injection. [0002] technical background [0003] Piperacillin sodium and tazobactam sodium are a type of penicillin antibiotics, and the polymer impurities contained in them are likely to induce allergic reactions in patients, which is a potential risk factor affecting drug safety. Most of these polymer impurities are endogenous impurities, which may be produced during the production, transportation and storage of raw materials and preparations of pharmaceuticals. Therefore, in order to ensure the safety of medicines, it is necessary to strictly control the content of polymer impurities in piperacillin sodium tazobactam sodium for injection. At present, the methods for polymer impurities in piperacillin sodium and tazobactam sodium for injection mainly include Sephadex G10 chromatography (SephadexG10 chromatography) and high performance g...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/431A61K31/496A61P31/04
CPCA61K9/0019A61K9/08A61K31/431A61K31/496A61P31/04A61K2300/00
Inventor 许前辉李文凯
Owner JIANGSU HAIHONG PHARMA
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