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UPLC analysis method for simultaneously measuring citicoline sodium and nine related substances

A technology of citicoline sodium and an analytical method, which is applied in the UPLC analysis field of simultaneous determination of citicoline sodium and nine related substances

Active Publication Date: 2019-08-27
苏州正济药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Publication No. CN105388225A discloses a method for analyzing and detecting UDPC in pharmaceutical preparations containing citicoline sodium, but the detection sample for this method is a preparation, and can only effectively separate the two components contained in citicoline sodium. Known impurities, i.e. 5'-cytidine and UDPC

Method used

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  • UPLC analysis method for simultaneously measuring citicoline sodium and nine related substances
  • UPLC analysis method for simultaneously measuring citicoline sodium and nine related substances
  • UPLC analysis method for simultaneously measuring citicoline sodium and nine related substances

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0077] High performance liquid chromatography: Waters H-class-VWD detector;

[0078] Mobile phase: Phase A: Phosphate buffer (phosphate buffer is 0.01mol / L potassium dihydrogen phosphate aqueous solution mixed with 0.01mol / L tetrabutylammonium hydroxide aqueous solution in equal proportions, adjust pH to 3.0 with phosphoric acid)

[0079] Phase B: Methanol;

[0080] The elution gradient is as follows:

[0081] Table 1 Elution Gradient Program

[0082]

[0083]

[0084] Column: Acquity HSS T3, 2.1*100mm, 1.8μm;

[0085] Detection wavelength: 280nm;

[0086] Flow rate: 0.2mL / min;

[0087] Column temperature: 30°C;

[0088] Injection volume: 1μL;

[0089] Blank solution: purified water.

[0090] Sample solution preparation: Accurately weigh about 10 mg of the sample, place it in a 50 mL measuring bottle, add purified water to dilute to the mark, and shake well.

[0091] System suitability solution preparation: Accurately weigh about 5 mg of citicoline sodium sampl...

Embodiment 2

[0095] High performance liquid chromatography: Waters H-class-VWD detector;

[0096] Mobile phase: Phase A: Phosphate buffer (phosphate buffer is 0.01mol / L potassium dihydrogen phosphate aqueous solution mixed with 0.01mol / L tetrabutylammonium hydroxide aqueous solution in equal proportions, adjust pH to 4.5 with phosphoric acid)

[0097] Phase B: Methanol;

[0098] The elution gradient is as follows:

[0099] Table 2 Elution Gradient Program

[0100]

[0101]

[0102] Column: Acquity HSS T3, 2.1*100mm, 1.8μm;

[0103] Detection wavelength: 280nm;

[0104] Flow rate: 0.2mL / min;

[0105] Column temperature: 30°C;

[0106] Injection volume: 1μL;

[0107] Blank solution: purified water.

[0108] Sample solution preparation: Accurately weigh about 10 mg of the sample, place it in a 50 mL measuring bottle, add purified water to dilute to the mark, and shake well.

[0109] System suitability solution preparation: Accurately weigh about 5 mg of citicoline sodium sampl...

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Abstract

The invention relates to the chemical field of medicine analysis, in particular to a UPLC analysis method for simultaneously measuring citicoline sodium and nine related substances. The method comprises the steps of performing chromatographic analysis by a reverse-phase chromatographic column, wherein the reverse-phase chromatographic column takes hydrophilic octadecyl silane bonded silica gel asa filling agent, phosphate buffer liquid as a moving phase A and an organic solvent as a moving phase B; performing gradient elution on a sample solution of the citicoline sodium; and measuring purityof the citicoline sodium and content of nine types of impurities according to an area normalization method. With the method provided by the technical scheme of the invention, the citicoline sodium impurity can be effectively separated, so that the quality of the citicoline sodium can be accurately controlled; and the detection advantage of a plurality of impurities of the citicoline sodium is displayed, and an accurate and high-efficiency detection method can be provided for measurement of the purity of the citicoline sodium and the impurity content.

Description

technical field [0001] The invention relates to the field of pharmaceutical analytical chemistry, in particular to a UPLC analysis method for simultaneously determining citicoline sodium and nine related substances. Background technique [0002] Citicoline sodium (Citicoline sodium), the chemical name is choline cytosine nucleoside diphosphate monosodium salt, its CAS number is: 33818-15-4, and its molecular formula is C 14 h 25 N 4 NaO 11 P 2 , molecular weight: 510.31, chemical structure: [0003] [0004] Citicoline sodium is mainly used for disturbance of consciousness after acute craniocerebral trauma and brain surgery. Citicoline is an intermediate substance in the biosynthesis of cell membrane structural phospholipids. Exogenous administration of citicoline can quickly repair neuronal cell membranes by increasing the synthesis of phospholipids, promote the synthesis of acetylcholine and dopamine, stabilize the neurotransmitter system, and promote the energy m...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 刘双刘南邓瑜姚青沈雨琦
Owner 苏州正济药业有限公司
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