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Element analysis method in a kind of lamivudine preparation

A technique for elemental analysis and lamivudine, which is applied in the analysis of materials, material analysis by electromagnetic means, preparation of samples for testing, etc. good effect

Active Publication Date: 2021-12-14
上海微谱检测科技集团股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the process of preparing lamivudine tablets, a certain amount of auxiliary materials can be added to tablet smoothly, and the main auxiliary materials are sodium carboxymethyl starch, magnesium stearate, silicon dioxide, etc. It will interfere with the test results during the determination of the component content

Method used

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  • Element analysis method in a kind of lamivudine preparation
  • Element analysis method in a kind of lamivudine preparation
  • Element analysis method in a kind of lamivudine preparation

Examples

Experimental program
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preparation example Construction

[0025] (1) Preparation of the sample to be tested: take the lamivudine tablet to be tested, add mixed acid to dissolve, digest, and constant volume, to obtain the solution to be tested;

[0026] (2) Sample spiked solution: take the lamivudine tablet to be tested and the standard mother liquor of sodium and magnesium elements, add mixed acid for dissolution, digestion, and constant volume, and obtain the sample spiked solution;

[0027] (3) Inductively coupled plasma mass spectrometry: use inductively coupled plasma mass spectrometer to detect and analyze standard solution and sample solution;

[0028] (4) Result analysis: standard curve drawing and method validation.

[0029] In some embodiments, the elements to be analyzed are sodium and magnesium.

[0030] In some embodiments, the test concentration range of the sodium element is 0.1-2.0 mg / L; the test range of the magnesium element is 0.05-1.0 mg / L.

[0031] 1. The inductively coupled plasma mass spectrometry in the prese...

Embodiment 1

[0077] Embodiment 1 provides a kind of elemental analysis method in lamivudine preparation, comprises the steps:

[0078] (1) Preparation of the sample to be tested: take the lamivudine tablet to be tested, add mixed acid to dissolve, digest, and constant volume, to obtain the solution to be tested;

[0079] (2) Preparation of the sample spiked solution: take the lamivudine tablet to be tested and the standard mother liquor of sodium and magnesium elements, add mixed acid for dissolution, digestion, and constant volume, and obtain the sample spiked solution;

[0080] (3) Inductively coupled plasma mass spectrometry: use inductively coupled plasma mass spectrometer to detect and analyze standard solution and sample solution;

[0081] (4) Result analysis: standard curve drawing and method validation.

[0082] The preparation step of described step (1) sample to be tested specifically comprises: the lamivudine sheet to be tested is placed in a beaker, adds 5ml mixed acid, digest...

Embodiment 2

[0110] Embodiment 2 provides a kind of element analysis method in lamivudine preparation, comprises the steps:

[0111] (1) Preparation of the sample to be tested: take the lamivudine tablet to be tested, add acid to dissolve, digest, and constant volume to obtain the test solution;

[0112] (2) Preparation of the sample spiked solution: take the lamivudine tablet to be tested and the standard mother liquor of sodium and magnesium elements, add acid for dissolution, digestion, and constant volume to obtain the sample spiked solution;

[0113] (3) Inductively coupled plasma mass spectrometry: use inductively coupled plasma mass spectrometer to detect and analyze standard solution and sample solution;

[0114] (4) Result analysis: standard curve drawing and method validation.

[0115] The difference between embodiment 2 and embodiment 1 is that the acid used for digestion is concentrated nitric acid (that is, no mixed acid is used).

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Abstract

The invention relates to the technical field of lamivudine detection, in particular to a method for analyzing elements in lamivudine preparations. Including the following steps: (1) preparation of the sample to be tested: take the lamivudine tablet to be tested, add mixed acid to dissolve, digest, and constant volume, and obtain the solution to be tested; (2) sample addition solution: take the lamivudine tablet to be tested Mivudine tablets and sodium and magnesium standard mother liquors were added to the mixed acid for dissolution, digestion, and constant volume to obtain the sample spiked solution; (3) Inductively coupled plasma mass spectrometry: the standard solution was analyzed by inductively coupled plasma mass spectrometry (4) Result analysis: standard curve drawing and method verification.

Description

technical field [0001] The invention relates to the technical field of lamivudine detection, in particular to a method for analyzing elements in lamivudine preparations. Background technique [0002] Hepatitis B is an epidemic infectious disease with high morbidity, strong infectivity, and serious harm to human health. It is a global public health problem. More than 300,000 people die of hepatitis B-related complications every year in my country, and the 5-year mortality rates of chronic hepatitis B, compensated and decompensated liver cirrhosis are 0%-2%, 14%-20% and 70%- 86%. The total cost of hepatitis B treatment in China exceeds 100 billion each year. Chronic hepatitis B and its complications not only bring great disease burden to patients, but also bring heavy economic burden to society and individuals. [0003] Lamivudine is an antiviral drug, which belongs to nucleoside reverse transcriptase inhibitors. It was first developed by Canadian BiochemPharma Company, and w...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N27/626G01N1/28G01N1/44
CPCG01N1/28G01N1/44G01N27/62G01N2001/2893
Inventor 吴杰贾梦虹秦秋明杨佳佳
Owner 上海微谱检测科技集团股份有限公司