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Analysis method for determining content of saccharin sodium and benzamide degradation impurities in amisulpride oral solution

A technology of benzamide and oral solution, which is applied in the field of medical analysis, can solve the problems of prone to bladder cancer and carcinogenic effects, and achieve the effects of strong specificity, strong accuracy and high precision

Active Publication Date: 2022-02-25
广东金城金素制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Experimental research was carried out on two generations of mice, the total amount of sodium saccharin contained in their diet was 5.0% to 7.5% (equivalent to 175g of human daily intake). The results showed that the second generation male mice taking sodium saccharin were more prone to Bladder cancer; further experiments in rats showed that a commercially available saccharin sodium contaminant, o-toluenesulfonamide, also had carcinogenic effects

Method used

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  • Analysis method for determining content of saccharin sodium and benzamide degradation impurities in amisulpride oral solution
  • Analysis method for determining content of saccharin sodium and benzamide degradation impurities in amisulpride oral solution
  • Analysis method for determining content of saccharin sodium and benzamide degradation impurities in amisulpride oral solution

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Experimental program
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Embodiment 1

[0043] Instrument: Diana U3000 High Performance Liquid Chromatograph

[0044] Chromatographic column: a chromatographic column filled with octyl silica gel (150*4.6mm, 5μm)

[0045] Mobile phase A: methanol-0.68% w / v potassium dihydrogen phosphate solution (adjust the pH value to 8.0 with 6mol / L ammonia water)=20:80

[0046] Mobile Phase B: Methanol

[0047] Flow rate: 1.0mL / min

[0048] Detector: UV

[0049] Detection wavelength: 240nm

[0050] Injection volume: 20μL

[0051] Column temperature: 25°C

[0052] The gradient elution is shown in Table 1 below:

[0053] Table 1

[0054] time (min) Mobile phase A(%) Mobile phase B(%) 0 100 0 30 100 0 35 75 25 45 75 25 50 100 0 60 100 0

[0055] Get amisulpride oral solution, dissolve with mobile phase A and dilute to contain sodium saccharin 0.33mg / mL, shake up, as need testing solution; Get sodium saccharin, impurity B, impurity E, impurity F reference substance respect...

Embodiment 2

[0060] Instrument: Diana U3000 High Performance Liquid Chromatograph

[0061] Chromatographic column: a chromatographic column filled with octyl silica gel (150*4.6mm, 5μm)

[0062] Mobile phase A: methanol-0.68% w / v potassium dihydrogen phosphate solution (adjust the pH value to 7.8 with 6mol / L ammonia water)=20:80

[0063] Mobile Phase B: Methanol

[0064] Flow rate: 1.0mL / min

[0065] Detector: UV

[0066] Detection wavelength: 240nm

[0067] Injection volume: 20μL

[0068] Column temperature: 25°C

[0069] The gradient elution is shown in Table 3 below:

[0070] table 3

[0071] time (min) Mobile phase A(%) Mobile phase B(%) 0 100 0 30 100 0 35 75 25 45 75 25 50 100 0 60 100 0

[0072] Get amisulpride oral solution, dissolve with mobile phase A and dilute to contain sodium saccharin 0.33mg / mL, shake up, as need testing solution; Get sodium saccharin, impurity B, impurity E, impurity F reference substance respect...

Embodiment 3

[0077] Instrument: Diana U3000 High Performance Liquid Chromatograph

[0078] Chromatographic column: a chromatographic column filled with octyl silica gel (150*4.6mm, 5μm)

[0079] Mobile phase A: methanol-0.73% w / v potassium dihydrogen phosphate solution (adjust the pH value to 8.2 with 6mol / L ammonia water)=20:80

[0080] Mobile Phase B: Methanol

[0081] Flow rate: 1.0mL / min

[0082] Detector: UV

[0083] Detection wavelength: 240nm

[0084] Injection volume: 20μL

[0085] Column temperature: 25°C

[0086] Gradient elution is shown in Table 5 below:

[0087] table 5

[0088] time (min) Mobile phase A(%) Mobile phase B(%) 0 100 0 30 100 0 35 75 25 45 75 25 50 100 0 60 100 0

[0089] Get amisulpride oral solution, dissolve with mobile phase A and dilute to contain sodium saccharin 0.33mg / mL, shake up, as need testing solution; Get sodium saccharin, impurity B, impurity E, impurity F reference substance respectivel...

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Abstract

The invention discloses an analysis method for determining the content of saccharin sodium and benzamide degradation impurities in an amisulpride oral solution, and belongs to the field of medicine analysis, the analysis method comprises the following steps: 1) preparing a test solution; 2) preparing a reference substance solution; 3) respectively taking the test solution and the reference solution for sample introduction, performing high performance liquid chromatography analysis, and calculating the content of saccharin sodium and benzamide degradation impurities in the test solution by peak area according to an external standard method. According to the analysis method, the contents of saccharin sodium and benzamide degradation products such as an impurity B, an impurity E and an impurity F in the amisulpride oral solution preparation are simultaneously determined by matching two conditions of gradient elution by taking octyl silane bonded silica gel as a filler and taking a mixed solvent of an organic phase and a buffer solution as a mobile phase; the method has the advantages of strong specificity, high precision, strong accuracy, no interference of a solvent in detection, and reliable and accurate detection result.

Description

technical field [0001] The invention relates to the field of medical analysis, in particular to an analysis method for determining the content of saccharin sodium and benzamide degradation impurities in amisulpride oral solution. Background technique [0002] Sodium saccharin is widely used as a sweetener in cosmetics, food and pharmaceutical preparations. It can be used alone or in combination with other additives. In oral solutions, sodium saccharin is the most commonly used sweetener. Sodium saccharin has no nutritional value to the human body. When eating more, it will affect the normal secretion of gastrointestinal digestive enzymes, reduce the absorption capacity of the small intestine, and reduce appetite. Many countries have restricted the use of sodium saccharin in food processing. In production and operation activities, a small number of enterprises illegally and excessively use food additives such as sodium saccharin in order to one-sidedly pursue the sweetness...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/36
CPCG01N30/02G01N30/06G01N30/34G01N30/36G01N2030/047
Inventor 周白水傅苗青朱旭伟李秋荣应鹏
Owner 广东金城金素制药有限公司
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