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Detection method of related substances of L-2-amino-5-mercaptovaleric acid

A technology of arginine and related substances, which is applied in the field of detection of L-2-amino-5-guanidinyl-related substances, can solve the problems of unexplainable existence, unfavorable quality control of preparations, hidden dangers of clinical drug safety, etc. problem, to achieve the effect of ensuring food and medicinal safety, good product quality control, and high sensitivity

Active Publication Date: 2019-03-19
FUJIAN GUTIAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Difficult to completely separate and remove mainly include 2-ketoglutaric acid, (S)-2-acetylaminoglutaric acid and (E)-2-butenedioic acid, etc., which tend to remain in L-2-amino-5- Arginine valeric acid raw materials, affecting product quality
The L-2-amino-5-guanidinopentanoic acid recorded in the current editions of national pharmacopoeias has no related substance inspection items, and it cannot be clearly stated that these organic acid homologue impurities are contained in L-2-amino-5-guanidinopentanoic acid The existing status in the raw material drug is also not conducive to the quality control of the preparation prepared by using the raw material, which brings safety hazards to clinical medication
The prior art has no related substances related to L-2-amino-5-guanidinovaleric acid raw materials, especially 2-ketoglutaric acid, (S)-2-acetylaminoglutaric acid and (E)-2- Quantitative detection of metabolic homologue impurities such as butenedioic acid

Method used

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  • Detection method of related substances of L-2-amino-5-mercaptovaleric acid
  • Detection method of related substances of L-2-amino-5-mercaptovaleric acid
  • Detection method of related substances of L-2-amino-5-mercaptovaleric acid

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Embodiment 1: Detection of three batches of L-2-amino-5-arginine bulk drug and its related substances

[0052] Instrument and chromatographic conditions:

[0053] An Agilent 1260 high performance liquid chromatograph was used, with octadecylsilane-bonded silica gel as the filler (4.6×250mm, 5μm), the column temperature was 30°C; the flow rate was 0.5mL / min; the detection wavelength was 210nm; Take 3.9 g of sodium dihydrogen phosphate, dissolve in water and dilute to 1000 mL, adjust the pH value to 2.3 with 20% phosphoric acid as mobile phase A, use acetonitrile as mobile phase B, and elute according to the following table, the ratio is as follows:

[0054]

[0055] Precisely measure 20 μL of the test solution, the reference solution and the reference solution, respectively, inject them into the liquid chromatograph, and record the chromatogram;

[0056] According to the external standard method, 2-ketoglutaric acid (impurity A), (S)-2-acetylaminoglutaric acid (impur...

Embodiment 2

[0065] Example 2: Location Test of Related Substances

[0066] The instruments and chromatographic conditions are the same as those in Example 1.

[0067] Experimental steps: Weigh appropriate amounts of impurity A, impurity B, and impurity C reference substance, respectively, dissolve and quantitatively dilute them with diluents to prepare a solution containing about impurity A, impurity B, 2.5 μg, and impurity C, 0.25 μg per 1 mL. The positioning solution of each impurity; the preparation method of the mixed solution is the same as that of the system suitability solution in Example 1, and the positioning solution and the mixed solution of the above-mentioned impurities are respectively injected into the liquid chromatograph, and the chromatogram is recorded. The separation results of L-2-amino-5-arginylvaleric acid and various impurities are shown in the following table, and the chromatogram is shown in the following table. image 3 :

[0068]

[0069] The results showe...

Embodiment 3

[0070] Example 3: Specificity Destruction Test

[0071] The instruments and chromatographic conditions are the same as those in Example 1.

[0072] Experimental steps: Weigh appropriate amounts of impurity A, impurity B, and impurity C reference substance, respectively, dissolve and quantitatively dilute them with diluent to prepare a solution containing about impurity A, impurity B, 2.5 μg, and impurity C, 0.25 μg per 1 mL. The positioning solution of impurities; the preparation method of the mixed solution is the same as that of the system suitability solution in Example 1, and the positioning solution and the mixed solution of the above-mentioned impurities are respectively injected into the liquid chromatograph, and the chromatogram is recorded. The separation results of L-2-amino-5-arginylvaleric acid and various impurities are shown in the following table, and the chromatogram is shown in the following table. image 3 :

[0073] Precisely weigh an appropriate amount of...

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Abstract

The invention discloses a detection method of related substances of L-2-amino-5-mercaptovaleric acid. The detection method comprises the steps of testing chromatographic conditions and system applicability, and determining the related substances of L-2-amino-5-mercaptovaleric acid. The detection method particularly comprises the following steps: calculating the contents of 2-ketoglutaric acid, (S)-2-acetamidoglutaric acid and (E)-2-butenedioic acid according to a peak area by virtue of an external standard method; and calculating the content of other single unknown impurities and the total content of other unknown impurities according to the main peak area of a contrast solution by virtue of a self-contrast method. The method has relatively high sensitivity, accuracy and precision and strong durability, is capable of accurately reflecting the content of the related substances of an L-2-amino-5-mercaptovaleric acid raw material drug and is suitable for the industrial detection and masscontrol of the related substances of L-2-amino-5-mercaptovaleric acid, so that basis is provided for the reasonable stimulation of quality standards, the quality of the products can be well controlledand grasped, and the eating and pharmaceutical safeties are guaranteed.

Description

technical field [0001] The invention belongs to the technical field of food and drug analysis, and in particular relates to a detection method for related substances of L-2-amino-5-guanidinovaleric acid. Background technique [0002] L-2-amino-5-guanidinovaleric acid (CAS registration number 74-79-3) belongs to amino acid compounds, has important physiological functions, is often used as nutritional supplements, and is also an important component of amino acid capsules and infusions. L-2-amino-5-guanidine valeric acid can effectively improve immunity, promote the immune system to secrete endogenous substances, help fight cancer cells and prevent virus infection; help patients with severe trauma and burns that require a large amount of tissue repair health care. Clinically, L-2-amino-5-guanidine valeric acid is suitable for hepatic coma with increased blood ammonia, especially for patients with alkalosis; it is used to assist in the determination of pituitary function; it is...

Claims

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Application Information

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IPC IPC(8): G01N30/88
CPCG01N30/88G01N2030/8818
Inventor 陈程俊李绪全刘红方佳茂陈伟滨林晓群张松浩陈榕兴
Owner FUJIAN GUTIAN PHARMA
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