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Method of detecting related substances of moxifloxacin hydrochloride by high performance liquid chromatography

A technology of moxifloxacin hydrochloride and high performance liquid chromatography, applied in the field of analytical chemistry, can solve problems such as undiscovered, and achieve the effects of being beneficial to durability, simplifying analysis methods, and improving drug safety

Pending Publication Date: 2019-11-19
SICHUAN KELUN PHARMA RES INST CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Invention patent CN201710154924.0 When using liquid chromatography to detect related substances in moxifloxacin hydrochloride injection, only 5 kinds of impurities can be detected, and no method has been found to detect 16 kinds of related substances in moxifloxacin hydrochloride

Method used

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  • Method of detecting related substances of moxifloxacin hydrochloride by high performance liquid chromatography
  • Method of detecting related substances of moxifloxacin hydrochloride by high performance liquid chromatography
  • Method of detecting related substances of moxifloxacin hydrochloride by high performance liquid chromatography

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] High performance liquid chromatography conditions:

[0049] Phenyl-bonded silica gel as filler, Agilent Poroshell 120 Phenyl Hexyl, 4.6mm×100mm, 2.7μm

[0050] Phosphate buffer solution: Take 0.5g of tetrabutylammonium hydrogensulfate, 1.0g of potassium dihydrogenphosphate and 2ml of phosphoric acid into a beaker, add 1000ml of water to dissolve, adjust the pH value to 3.0 with triethylamine, and filter with suction to obtain the solution;

[0051] Mobile phase A: Phosphate buffer-methanol (80:20);

[0052] Mobile phase B: Phosphate buffer-methanol (20:80);

[0053] Flow rate: 0.8ml / min; Column temperature: 37°C; Detection wavelength: 293nm; Injection volume: 20μl;

[0054] The gradient elution procedure is as follows:

[0055]

[0056] Solution preparation:

[0057] Diluent: Weigh 50mg of anhydrous sodium sulfite, 0.5g of tetrabutylammonium bisulfate, 1.0g of potassium dihydrogen phosphate and 2ml of phosphoric acid, add water to dissolve and dilute to 1000ml; ...

Embodiment 2

[0073] High performance liquid chromatography conditions:

[0074] Chromatographic column: phenyl bonded silica gel as filler, Agilent Poroshell 120 Phenyl Hexyl, 4.6mm×100mm, 2.7μm;

[0075] Phosphate buffer solution: Take 0.5g of tetrabutylammonium hydrogensulfate, 1.0g of potassium dihydrogenphosphate and 2ml of phosphoric acid into a beaker, add 1000ml of water to dissolve, adjust the pH value to 2.0 with triethylamine, and filter with suction to obtain the solution;

[0076] Mobile phase A: Phosphate buffer-methanol (80:20);

[0077] Mobile phase B: Phosphate buffer-methanol (20:80);

[0078] Flow rate: 0.8ml / min; Column temperature: 37°C; Detection wavelength: 293nm; Injection volume: 20μl;

[0079] The gradient elution procedure is as follows:

[0080]

[0081] Solution preparation is with embodiment 1;

[0082] Take 20 μl of the system suitability solution, inject it into the liquid chromatograph, and record the chromatogram as attached figure 2 shown. From a...

Embodiment 3

[0086] High performance liquid chromatography conditions:

[0087] Chromatographic column: phenyl bonded silica gel as filler, Agilent Poroshell 120 Phenyl Hexyl, 4.6mm×100mm, 2.7μm;

[0088] Phosphate buffer solution: Take 0.5g of tetrabutylammonium hydrogensulfate, 1.0g of potassium dihydrogenphosphate and 2ml of phosphoric acid into a beaker, add 1000ml of water to dissolve, adjust the pH value to 3.0 with triethylamine, and filter with suction to obtain the solution;

[0089] Mobile phase A: Phosphate buffer-methanol (80:20);

[0090] Mobile phase B: Phosphate buffer-methanol (20:80);

[0091] Flow rate: 0.8ml / min; Column temperature: 37°C; Detection wavelength: 282nm; Injection volume: 20μl;

[0092] The gradient elution procedure is as follows:

[0093]

[0094] Solution preparation is with embodiment 1;

[0095] Take 20 μl of the system suitability solution, inject it into the liquid chromatograph, and record the chromatogram as attached image 3 shown. From at...

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Abstract

The invention belongs to the field of analytical chemistry, and particularly relates to a detection method of related substances of moxifloxacin hydrochloride. Phenyl bonding silica gel is selected and used as a chromatographic column of a filler, and the mixed solvent gradient elution of a buffer and an organic phase is used as mobile phases for detection. The method realizes effective separationon 16 types of impurities of the moxifloxacin hydrochloride under the same chromatographic column condition through improvement on technology of the chromatographic column, elution gradients, columntemperature and the like. The method is good in stability, has good specificity, is high in sensitivity, and is high in resolution.

Description

technical field [0001] The invention belongs to the field of analytical chemistry, and in particular relates to a method for detecting related substances of moxifloxacin hydrochloride. Background technique [0002] Moxifloxacin hydrochloride (Moxifloxacin hydrochloride), chemical name: 1-cyclopropyl-6-fluoro-7-((4aS,7aS)-1H- [0003] [3,4-b]hexahydropyridodihydropyrrole-6(2H))-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylate hydrochloride, the structural formula is as follows : [0004] [0005] Moxifloxacin hydrochloride is an extended-spectrum quinolone antibiotic developed by Bayer Pharmaceutical Company of Germany. It was first launched in Germany in September 1999 and was approved by FDA in December of the same year. Moxifloxacin hydrochloride is an 8-methoxyfluoroquinolone antibacterial drug with broad-spectrum antibacterial activity and strong bactericidal effect. It is effective against Gram-positive bacteria, Gram-negative bacteria, anaerobic bacteria, acid-f...

Claims

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 张诗静王伟熊彩虹胡敏赵忠琼韩庆平王利春王晶翼
Owner SICHUAN KELUN PHARMA RES INST CO LTD
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