Method for measuring calcium stearate in drug

A technology of calcium stearate and methyl stearate, applied in the field of analytical chemistry, can solve problems such as inability to accurately quantify calcium stearate, and achieve the effects of fast determination method and low detection limit

Active Publication Date: 2013-09-11
SGS STANDARD TECHNICAL SERVICES SHANGHAI CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, most of these methods are qualitative or preliminary quantitative, and cannot accurately quantify calcium stearate

Method used

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  • Method for measuring calcium stearate in drug
  • Method for measuring calcium stearate in drug
  • Method for measuring calcium stearate in drug

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Embodiment 1: the mensuration of calcium stearate in sodium chloride injection

[0029] 1. Sample preparation:

[0030] Take 4 mL of sodium chloride injection, add 400 mL of hydrochloric acid, mix well, and ultrasonically acidify in a water bath at 60 ° C for 1 hour. After the sample is cooled, transfer the sample solution to a 125 mL separating funnel, add 20 mL of water and mix well, divide it into 3 times with 60 mL of n-hexane For extraction, the n-hexane extract was dehydrated with anhydrous sodium sulfate, concentrated to less than 2mL with a rotary evaporator at 40°C, transferred the solution to a 10mL glass centrifuge tube, and blown dry with nitrogen.

[0031] Add 1mL of methanol to dissolve the residue, add 100uL of concentrated sulfuric acid and mix well, heat in a water bath at 30°C for 20 minutes, add 2mL of water and 1mL of n-hexane, vortex mix for 1 minute, let stand to separate layers, and take the n-hexane layer for GC / MS analysis. Measure the amount o...

Embodiment 2

[0054] Embodiment 2: the mensuration of calcium stearate in the antibiotic cefminox sodium for injection

[0055] 1. Sample preparation:

[0056] Weigh 4.0g of uniform drug powder, add 40ml of water to ultrasonically dissolve the sample, pipette 2mL of the sample solution into a 40mL glass bottle, add 400% hydrochloric acid, mix well, ultrasonically acidify in a water bath at 60°C for 1 hour, and transfer the sample solution to 125mL after the sample is cooled In the separatory funnel, add 20mL water and mix well, extract 60mL n-hexane for 3 times, dehydrate the n-hexane extract with anhydrous sodium sulfate, concentrate to less than 2mL with a rotary evaporator at 40°C, transfer the solution to a 10mL glass centrifuge tube, blow with nitrogen Dry.

[0057]Add 1mL of methanol to dissolve the residue, add 100uL of concentrated sulfuric acid and mix well, heat in a water bath at 30°C for 20 minutes, add 2mL of water and 1mL of n-hexane, vortex mix for 1 minute, let stand to sep...

Embodiment 3

[0081] Embodiment 3: the mensuration of calcium stearate in the antibiotic cefoxitin sodium for injection

[0082] 1. Sample preparation:

[0083] Weigh 4.0g of uniform drug powder, add 40ml of water to ultrasonically dissolve the sample, pipette 2mL of the sample solution into a 40mL glass bottle, add 400% hydrochloric acid, mix well, ultrasonically acidify in a water bath at 60°C for 1 hour, and transfer the sample solution to 125mL after the sample is cooled In the separatory funnel, add 20mL water and mix well, extract 60mL n-hexane for 3 times, dehydrate the n-hexane extract with anhydrous sodium sulfate, concentrate to less than 2mL with a rotary evaporator at 40°C, transfer the solution to a 10mL glass centrifuge tube, blow with nitrogen Dry.

[0084] Add 1mL of methanol to dissolve the residue, add 100uL of concentrated sulfuric acid and mix well, heat in a water bath at 30°C for 20 minutes, add 2mL of water and 1mL of n-hexane, vortex mix for 1 minute, let stand to s...

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Abstract

The invention belongs to the technical field of analysis chemistry and particularly relates to a method for measuring calcium stearate in a drug. The method comprises the following steps of: 1) extracting a sample solution, adding hydrochloric acid to the sample solution to acidize the sample solution, extracting through normal hexane to obtain a normal hexane extracting solution, rotationally evaporating and concentrating the normal hexane extracting solution, and blowing to dryness by using nitrogen; 2) carrying out methyl esterifying, namely, adding methanol into the solution to dissolve, adding sulfuric acid, uniformly mixing, and extracting a methyl esterified product through normal hexane, helically and uniformly mixing, stewing for layering and extracting the normal hexane layer; 3) measuring the dosage of the methyl stearate in the normal hexane layer obtained in step 2) through a gas chromatograph-mass spectrometer; and 4) finally calculating the content of calcium stearate in the sample solution according to the dosage of the methyl stearate obtained in step 3). The method disclosed by the invention is used for measuring calcium stearate in the drug through the gas chromatograph-mass spectrometer by acidizing the sample to extract stearic acid; and the measuring method is not only quick and simple, but also capable of being used for accurately measuring the content of calcium stearate in the drug, and the detection limit is low.

Description

[technical field] [0001] The invention belongs to the technical field of analytical chemistry, in particular to a method for determining calcium stearate in medicines. [Background technique] [0002] In modern pharmaceutical packaging, plastic products are widely used as the main body of pharmaceutical packaging, and rubber or plastic materials are used as sealing plugs or gaskets for medicine bottles. Since these packaging materials are in contact with drugs that enter the human body, there are strict requirements for drug packaging materials. Only in the chemical properties of these packaging materials must detection of extracts such as additives in materials, monomer residues, decomposition / degradation products, and There are migration of monomers such as additives, monomer residues, decomposition / degradation products, adhesives, inks, etc. Common additives in plastic packaging materials include modifiers, stabilizers, colorants, lubricants, etc. [0003] Calcium steara...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06
Inventor 刘平年冯颖俞安敏何志明
Owner SGS STANDARD TECHNICAL SERVICES SHANGHAI CO LTD
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