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HPLC detection method for L-malic acid related substances

A detection method and a technology for related substances, applied in the field of medical detection, can solve the problems of inability to effectively separate L-malic acid dimer impurities and the like

Active Publication Date: 2021-04-30
SHIJIAZHUANG NO 4 PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0004] There is no research on L-malic acid dimer impurities in the prior art and the Pharmacopoeia, and neither the prior art nor the Pharmacopoeia methods ca

Method used

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  • HPLC detection method for L-malic acid related substances
  • HPLC detection method for L-malic acid related substances
  • HPLC detection method for L-malic acid related substances

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] 1. Instruments and conditions:

[0029] High performance liquid chromatography: Hitachi L-2000;

[0030] Chromatographic column: C18 column (250mm×4.6mm, 3.5μm);

[0031] Column temperature: 35°C;

[0032] Mobile phase: 20mmol / L sodium dihydrogen phosphate aqueous solution, pH 2.6;

[0033] Flow rate: 0.5mL / min;

[0034] Detection wavelength: 210nm;

[0035] Injection volume: 80μL;

[0036] Elution method: isocratic elution;

[0037] Need testing solution: take L-malic acid need testing 250mg, accurately weigh, place in 25mL measuring bottle, dilute to scale with mobile phase, as need testing solution;

[0038] The self-contrast solution of the test product: accurately measure an appropriate amount of the test product solution, dilute it 1000 times with the mobile phase, and use it as the self-control solution of the test product;

[0039] Reference substance solution: in order to ensure product quality, the present embodiment carries out the preparation of refer...

Embodiment 2

[0048] 1. Instruments and conditions:

[0049] High performance liquid chromatography: Hitachi L-2000;

[0050] Chromatographic column: C18 column (250mm×4.6mm, 3.5μm);

[0051] Column temperature: 20°C;

[0052] Mobile phase: 5mmol / L sodium dihydrogen phosphate aqueous solution, pH 2;

[0053] Flow rate: 0.1mL / min;

[0054] Detection wavelength: 210nm;

[0055] Injection volume: 1μL;

[0056] Elution method: isocratic elution;

[0057] Need testing solution, need testing self contrast solution, reference substance solution and system suitability solution are identical with embodiment 1.

[0058] 2. Detection method

[0059] The detection method is the same as in Example 1.

[0060] The results of the related substance content (fumaric acid, maleic acid, tartaric acid, L-malic acid dimer, other individual impurities and other total impurities) in the need testing solution obtained through testing are basically the same as the detection results of Example 1. quite.

Embodiment 3

[0062] 1. Instruments and conditions:

[0063] High performance liquid chromatography: Hitachi L-2000;

[0064] Chromatographic column: C18 chromatographic column (250mm×4.6mm, 5μm);

[0065] Column temperature: 40°C;

[0066]Mobile phase: 100mmol / L sodium dihydrogen phosphate aqueous solution, pH 5;

[0067] Flow rate: 1mL / min;

[0068] Detection wavelength: 210nm;

[0069] Injection volume: 100μL;

[0070] Elution method: isocratic elution;

[0071] Need testing solution, need testing self contrast solution, reference substance solution and system suitability solution are identical with embodiment 1.

[0072] 2. Detection method

[0073] The detection method is the same as in Example 1.

[0074] The results of the related substance content (fumaric acid, maleic acid, tartaric acid, L-malic acid dimer, other individual impurities and other total impurities) in the need testing solution obtained through testing are basically the same as the detection results of Example...

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Abstract

The invention relates to the technical field of medicine detection, and particularly discloses an HPLC detection method for L-malic acid related substances. According to the HPLC detection method for the L-malic acid related substances, HPLC detection conditions are as follows: a chromatographic column is a hydrophilic C18 column; a column temperature is 20-40 DEG C; a mobile phase is a 5-100mmol/L sodium dihydrogen phosphate aqueous solution, and a pH value is 2-5; a flow rate is 0.1-1 mL/min; a detection wavelength is 210 nm; and an elution mode is isocratic elution. According to the HPLC detection method for the L-malic acid related substances, impurities, especially tartaric acid, maleic acid, fumaric acid and L-malic acid dimer impurities, in L-malic acid can be effectively separated, a peak shape and a separation degree are good, detection of the L-malic acid dimer impurities in the L-malic acid can be met, and reliable guarantee is provided for improving and controlling the quality of the L-malic acid.

Description

technical field [0001] The invention relates to the technical field of medical detection, in particular to an HPLC detection method for substances related to L-malic acid. Background technique [0002] L-malic acid is the left-handed isomer of malic acid. It has important physiological functions. It is an important intermediate product in the internal circulation of the human body and is easily absorbed by the human body. It can be used to treat liver disease, anemia, low immunity, uremia, high Blood pressure, liver failure and other diseases, and can reduce the toxic effect of anticancer drugs on normal cells. L-malic acid has been widely used in the field of medicine, but the existing research on the impurities of L-malic acid mainly focuses on fumaric acid and maleic acid, and the research on related impurities of L-malic acid is still incomplete. [0003] In the process of studying the stability of L-malic acid, the technicians of the present invention discovered a degr...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 孙立杰苏燕段孟彤石俭石笑笑
Owner SHIJIAZHUANG NO 4 PHARMA
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