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High performance liquid detection method for content of D-Carnitine in levocarnitine and levocarnitine salt product

A technology of middle-right carnitine and detection method, applied in the field of drug analysis, can solve the problems of complex method, long time-consuming and the like, and achieve the effect of high sensitivity

Active Publication Date: 2015-06-10
NORTHEAST PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, regarding the high-performance liquid phase detection method of the content of dex-carnitine in levocarnitine and its salts, after derivatizing this product, carry out chromatographic separation with a C18 column, the detector is a fluorescence detector, the method is more complicated and time consuming

Method used

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  • High performance liquid detection method for content of D-Carnitine in levocarnitine and levocarnitine salt product
  • High performance liquid detection method for content of D-Carnitine in levocarnitine and levocarnitine salt product
  • High performance liquid detection method for content of D-Carnitine in levocarnitine and levocarnitine salt product

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Choice of Chromatographic Conditions

[0027] 1 Selection of detection wavelength

[0028] Take appropriate amount of levocarnitine, dexcarnitine, and levocarnitine impurity A, add water to dissolve and dilute to make solutions with concentrations of 2mg / ml, 2mg / ml and 0.02mg / ml respectively. The UV spectrum shows that levocarnitine, dexcarnitine, and levocarnitine impurity A are end-absorbed. In order to ensure detection sensitivity and system stability, 205nm was selected as the detection wavelength in consideration of the cut-off wavelength of the solvent used.

[0029] 2 Selection of chromatographic column

[0030] Choose from two chiral chromatographic columns, normal phase and reverse phase. When using a normal-phase chiral chromatographic column, the peak time of the three components is very fast and they overlap together and cannot be separated; the β-cyclodextrin and its derivatives in the reverse-phase chiral chromatographic column have the best effect as fi...

Embodiment 2

[0036] Establishment of methodology

[0037] 1 specificity test

[0038] Precisely measure 10 μl of solvent water and system suitability test solution, inject it into the liquid chromatograph, and record the chromatogram. The degree of separation between impurities A is greater than 1.5.

[0039] 2 Linear range

[0040] Accurately weigh about 0.2114g of levocarnitine reference substance, put it in a 10ml volumetric flask, add water to dissolve and dilute to the mark, shake well, and accurately measure 0.1, 0.25, 0.5, 0.75, 1.0ml of the above solution and place them in five 100ml In a volumetric flask, dilute to the mark with water, shake well, accurately measure 10 μl into the liquid chromatograph, and record the chromatogram. Take the peak area (A) as the ordinate, and the concentration (C) as the abscissa to perform linear regression, and get the regression equation A=403548C-4086.8 r 2 =0.9994 (n=5), the results show that levocarnitine has a good linear relationship in ...

Embodiment 3

[0059] Determination of Dexcarnitine Content in Samples

[0060] 1. Chromatographic conditions:

[0061] Column: Astec CYCLOBOND TM I 2000 chiral column (250mm×4.6 mm, 5μm); detection wavelength: 205nm; mobile phase: triethylamine-acetic acid aqueous solution-acetonitrile (volume ratio 25:75); flow rate: 1.0 ml / min; column temperature: 10 -30°C, injection volume 10μl.

[0062] 2. Preparation of relevant solutions and mobile phases:

[0063] 2.1 Preparation of relevant solutions

[0064] 2.1.1 Preparation of triethylamine-acetic acid aqueous solution:

[0065] Precisely measure 1.5ml of triethylamine reagent, add 900ml of water, adjust the pH to 6.0 with 50% glacial acetic acid aqueous solution, and then add water to 1000ml;

[0066] 2.1.2 Preparation of system suitability solution

[0067] Accurately weigh 0.2056g of levocarnitine reference substance and 2.45mg of dexcarnitine reference substance, and put them in the same 10ml volumetric flask; take another 2.31mg o...

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Abstract

The invention discloses a high performance liquid detection method for the contents of D-Carnitine in levocarnitine and a levocarnitine product, and belongs to the field of medicament detection. According to the method, a chiral stationary phase high performance liquid chromatography method is adopted; a chiral stationary phase is formed by bonding cyclodextrin and a derivative of cyclodextrin with a silica gel filler, so that the separation effect of three components such as levocarnitine, D-Carnitine and levocarnitine impurities A is good, and the method is high in repetitiveness and durability; a flowing phase adopts a triethylamine-acetic acid aqueous solution and an acetonitrile system; the flowing phase is basically lossless relative to a chiral chromatographic column; the chromatographic peak retention time is high in repetitiveness, and the peak type is symmetric.

Description

technical field [0001] The invention relates to a high-efficiency liquid phase detection method for the content of dex-carnitine in levocarnitine and its salt products in the field of drug analysis. Background technique [0002] Levocarnitine, also known as L-carnitine, its chemical name is (R)-3-carboxy-2-hydroxy-N,N,N-trimethyl-1-propanamine hydroxide, inner salt, It is an internationally recognized safe and harmless nutritional agent. The commonly used salts are levocarnitine hydrochloride, levocarnitine tartrate and so on. L-carnitine is an essential natural substance in the energy metabolism of mammals, and its main function is to promote lipid metabolism. It can not only bring long-chain fatty acids into the mitochondrial matrix, promote their oxidation and decomposition, provide energy for cells, but also export short-chain fatty acyl groups produced in mitochondria. The supplementation of this product can alleviate the dysfunction of fat metabolism disorders, sk...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 王虹王洁黄文姝刘心董爱军岳静刘佳
Owner NORTHEAST PHARMA GRP
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