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HPLC detection method for biapenem side chain related substances

A technology for biapenem side chain and related substances, which is applied in the field of HPLC detection of biapenem side chain related substances, can solve problems such as the related research without the detection of biapenem side chain, achieve good separation and improve sensitivity , the effect of increased sensitivity

Active Publication Date: 2020-07-03
JIANGSU SIMCERE PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, there is no relevant research on the detection of related substances in the side chain of biapenem

Method used

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  • HPLC detection method for biapenem side chain related substances
  • HPLC detection method for biapenem side chain related substances
  • HPLC detection method for biapenem side chain related substances

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060] 1) Chromatographic conditions:

[0061] Instrument: Agilent1260 HPLC, the detector is an ultraviolet detector;

[0062] Chromatographic column: Agilent Eclipse plus C18 (4.6×150mm, 3.5μm);

[0063] Mobile phase A: pH 3.5 phosphate buffer (take 1.36g of potassium dihydrogen phosphate, 4.33g of sodium octane sulfonate, add 1000ml of water to dissolve, adjust the pH value to 3.5 with phosphoric acid);

[0064] Mobile phase B: acetonitrile;

[0065]

[0066]

[0067] Column temperature: 25°C

[0068] Flow rate: 1.0ml / min

[0069] Injection volume: 5μl

[0070] Wavelength: 210nm

[0071] 2) Sample preparation:

[0072] Test solution: Accurately weigh about 40mg of the side chain of biapenem, put it in a 5ml measuring bottle, dissolve it with water and dilute to the mark, shake well to get ready.

[0073] 3) Measurement result: the chromatogram of need testing solution sees figure 1 , higher sensitivity than the side chain of apenem, and better separation betwee...

Embodiment 2

[0079] 1) Chromatographic conditions:

[0080] Instrument: Agilent1260 HPLC, the detector is an ultraviolet detector;

[0081] Chromatographic column: Agilent Eclipse plus C18 (4.6×150mm, 3.5μm);

[0082] Mobile phase A: pH 3.5 phosphate buffer (take 1.36g of potassium dihydrogen phosphate, 3.76g of sodium hexanesulfonate, add 1000ml of water to dissolve, adjust the pH value to 3.5 with phosphoric acid);

[0083] Mobile phase B: acetonitrile;

[0084]

[0085] Column temperature: 25°C

[0086] Flow rate: 1.0ml / min

[0087] Injection volume: 5μl

[0088] Wavelength: 210nm

[0089] 2) Sample preparation:

[0090] Test solution: Accurately weigh about 40mg of the side chain of biapenem, put it in a 5ml measuring bottle, dissolve it with water and dilute to the mark, shake well to get ready.

[0091] 3) Measurement result: the chromatogram of need testing solution sees figure 2 , higher sensitivity than the side chain of apenem, and better separation between the main p...

Embodiment 3

[0093] 1) Chromatographic conditions:

[0094] Instrument: Agilent1260 HPLC, the detector is an ultraviolet detector;

[0095] Chromatographic column: Waters XBridge C18 (4.6×150mm, 3.5μm);

[0096] Mobile phase A: pH 3.5 phosphate buffer (take 1.36g of potassium dihydrogen phosphate, 4.33g of sodium octane sulfonate, add 1000ml of water to dissolve, adjust the pH value to 3.5 with phosphoric acid);

[0097] Mobile phase B: acetonitrile;

[0098]

[0099]

[0100] Column temperature: 25°C

[0101] Flow rate: 1.0ml / min

[0102] Injection volume: 5μl

[0103] Wavelength: 210nm

[0104] 2) Sample preparation:

[0105] Test solution: Accurately weigh about 40mg of the side chain of biapenem, put it in a 5ml measuring bottle, dissolve it with water and dilute to the mark, shake well to get ready.

[0106] 3) Measurement result: the chromatogram of need testing solution sees image 3 , higher sensitivity than the side chain of apenem, and better separation between the ...

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Abstract

The invention discloses an HPLC detection method of biapenem side chain related substances. Linear gradient elution is carried out by using octadecylsilane chemically bonded silica as a filler and using a mixed solution of a buffer solution of which the pH value is 3.0-4.5 and an organic solvent as a mobile phase. The detection sensitivity of the detection method provided by the invention is obviously improved compared with that of related substances of the apixem side chain, the separation degree of each impurity and a main peak is very good, and the increase of hydrolyzed impurities can be effectively controlled.

Description

technical field [0001] The invention relates to the technical field of antibiotics, in particular to an HPLC detection method for related substances of biapenem side chains. Background technique [0002] The side chain of biapenem belongs to the raw material of medicine and pharmaceutical, which can be used to produce biapenem antibiotic medicine. Biapenem (Biapenem, LJC 10627) is a carbapenem antibiotic for injection developed by Lederle Company of Japan and Cyamide Company of the United States in 1989. It has completed phase III clinical research in Japan and is waiting for approval for marketing. The most notable feature of this product is the 1β-methyl carbapenem with bicyclic triazole on the 2-position S. The study of structure-activity relationship shows that the existence of the side chain quaternary ammonium cationic center is the key to affecting the permeability of the outer membrane, which makes the activity of this product against Pseudomonas aeruginosa and anae...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 雷晓雪王霞刘军花朱建新李薇任晋生
Owner JIANGSU SIMCERE PHARMA
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