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Method for detecting sodium pantothenate isomers

A detection method, the technology of sodium pantothenate, applied in the direction of measuring devices, instruments, scientific instruments, etc., to achieve the effects of high precision, good stability, and high system applicability

Active Publication Date: 2019-01-04
珠海润都制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there is no literature report on the detection method of sodium pantothenate isomers. The present invention proposes a detection method of sodium pantothenate isomers for the first time, using the reagent amylose-tris(3,5-xylylcarbamate) Derivatives Pre-column derivatization of the isomer L-sodium pantothenate in D-sodium pantothenate, so as to realize the separation and determination of the isomer L-sodium pantothenate in D-sodium pantothenate

Method used

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  • Method for detecting sodium pantothenate isomers
  • Method for detecting sodium pantothenate isomers
  • Method for detecting sodium pantothenate isomers

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] (1) Experimental materials and instrument conditions

[0046] Instrument: High performance liquid chromatography: Thermo; Chromatographic column: Chiralpak AD-H, 5 μm, 4.6×250 mm; Flow rate: 1.0mL / min; Column temperature: 25°C; Injection volume: 10 μl; Running time: 15min; Detection Wavelength: 210nm. Inject the blank solution, system suitability solution and test solution into the liquid chromatograph respectively, record the chromatogram, and the chromatographic conditions are as follows: Chromatographic column: use amylose-tris(3,5-xylylcarbamate) derivative As filler; flow rate 1.0mL / min; column temperature: 25°C; injection volume: 10μl; running time: 15min; detection wavelength: 210nm; mobile phase: n-hexane-isopropanol-trifluoroacetic acid, gradient elution , and its gradient is shown in Table 1.

[0047] Table 1 - Gradient Elution Conditions

[0048] time (min)

mobile phase A

mobile phase B

mobile phase C

0

85

15

0.2

5 ...

Embodiment 2

[0063] Embodiment 2 detection method system applicability test of the present invention

[0064] System suitability is achieved by measuring the RSD of the peak area of ​​D-sodium pantothenate in the 5-pin reference solution and the resolution of the peaks of D-sodium pantothenate and L-sodium pantothenate in the system suitability solution. The RSD of the peak area of ​​D-sodium pantothenate is ≤2.0%, and the resolution of the peaks of D-sodium pantothenate and L-sodium pantothenate in the system suitability solution is ≥1.5. Prepare blank solution, reference solution, and system suitability solution as described in Example 1. Under the chromatographic conditions described in Example 1, enter 1 needle of blank solution, 5 needles of reference solution, and 1 needle of system suitability solution to obtain a chromatogram Figure, such as figure 1 , figure 2 , image 3 , Figure 4 , Figure 5 and Image 6 , according to the formula conversion results are shown in the tabl...

Embodiment 3

[0068] Embodiment 3 Detection method specificity test of the present invention

[0069] The specificity of the method is realized by studying the peak identification and selectivity, and it is required that the blank solvent does not interfere with the detection; the D-sodium pantothenate positioning solution has no interference with the detection of L-sodium pantothenate; The resolution of adjacent peaks should be ≥1.5, and the recovery rate of sodium L-pantothenate should be between 90.0% and 110.0%. Prepare blank solution, DL-sodium pantothenate stock solution, L-sodium pantothenate fixing solution (system suitability solution), D-sodium pantothenate fixing solution and selective solution as described in Example 1. After the system is balanced, inject 1 needle of blank solution, 3 needles of L-sodium pantothenate positioning solution, 3 needles of selective solution, and 1 needle of D-sodium pantothenate positioning solution, and record the chromatogram, as figure 1 , fi...

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Abstract

The invention aims to provide a method for detecting sodium pantothenate isomers. The method comprises the following steps: performing pre-column derivatization on an isomer sodium L-pantothenate in sodium D-pantothenate by adopting a reagent amylase-tris(3,5-dimethylphenyl carbamate) derivative, thereby realizing separation and determination of the isomer sodium L-pantothenate in the sodium D-pantothenate. Therefore, the method completely accords with the guiding principle of validation of the Chinese pharmacopoeia method in aspects such as system suitability, specificity, precision degree, detection limit, limit of quantitation, linearity and range, accuracy, durability and the like, and can be used for quality control of sodium pantothenate bulk drugs.

Description

technical field [0001] The invention relates to a method for determining sodium pantothenate isomers by HPLC, and belongs to the technical field of drug analysis. Background technique [0002] Sodium pantothenate (CAS No.: 867-81-2) is a white crystal or crystalline powder, its English name is D-Pantothenic Acid Sodium Salt, its alias is D-pantothenic sodium, its chemical name is (R)-N-(2,4- Dihydroxy-3,3-dimethyl-1-oxobutyl)-beta-alanine monosodium salt, the sodium salt form of vitamin B5. The trade name of pantothenic acid is Unithroid, which is a vitamin drug and a precursor of coenzyme A (CoA). It participates in the metabolism of proteins, fats, and sugars in the body. It is used for various diseases that require vitamin supplementation, and supplements to maintain normal physiological metabolism essential nutrients. Sodium pantothenate is clinically used in the treatment of vitamin B deficiency, peripheral neuritis, and colic after surgery. It can be used in combinat...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06G01N2030/067
Inventor 韦静谢金昌王晴晴祁红林黄肖艳蔡强周爱新
Owner 珠海润都制药股份有限公司
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