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Method for determining glycidol in glycerine enema raw material

A technology of glycidol and Kaisailu, which is applied in the direction of measuring devices, material separation, and analysis materials, etc., can solve the problems of solvent and glycerin interference, glycidol peak time is too fast, etc.

Pending Publication Date: 2021-05-07
FRONT PHARM PLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] By screening the chromatographic column, solvent, gradient program and other conditions, the problem of rapid peak eluting time of glycidol in the gas phase and serious interference between solvent and glycerin has been successfully solved. This method is simple and easy to implement, with high accuracy and good separation

Method used

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  • Method for determining glycidol in glycerine enema raw material
  • Method for determining glycidol in glycerine enema raw material
  • Method for determining glycidol in glycerine enema raw material

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Embodiment 1: The recovery experiment of phenoxyethanol detection in the glycerol raw material

[0023] Instrument: Agilent 7890B gas chromatograph

[0024] Chromatographic conditions:

[0025] Capillary column (recommended to use DB-FFAP; 0.53mm×60m, 1μm) with polyethylene glycol modified with nitroterephthalic acid as the stationary phase (or a stationary phase with similar polarity), temperature programmed, initial temperature Maintain 120°C for 2 minutes; heat up to 140°C at a rate of 2°C per minute; heat up to 250°C at a rate of 50°C per minute and maintain for 10 minutes; then decrease to 120°C at a rate of 50°C per minute and maintain for 10 minutes minutes; the inlet temperature is 200°C, and the detector temperature is 250°C.

[0026] Experimental steps:

[0027] Reference substance stock solution: take 20mg of glycidol reference substance, accurately weigh it, put it in a 25ml measuring bottle, dissolve it with methanol and dilute to the mark, shake well, a...

Embodiment 2

[0035] Example 2: Detection limit and quantification limit experiment of phenoxyethanol detection in glycerin raw material

[0036] Instrument: Agilent 7890B gas chromatograph

[0037] Chromatographic conditions:

[0038] Use polyethylene glycol modified with nitroterephthalic acid as the stationary phase capillary column (DB-FFAP is recommended; inner diameter 0.53mm, length 60m, film thickness 1μm), temperature program, the initial temperature is 120 ℃ and maintained for 2 minutes; heat up to 140°C at a rate of 2°C per minute; heat up to 250°C at a rate of 50°C per minute and maintain for 10 minutes; then decrease to 120°C at a rate of 50°C per minute and maintain for 10 minutes; The temperature is 200°C, and the detector temperature is 250°C.

[0039]Experimental steps:

[0040] Reference substance solution: take 20mg of glycidol reference substance, weigh it accurately, put it in a 25ml volumetric flask, add methanol to dissolve and dilute to the mark, shake well, then ...

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Abstract

The invention provides a method for determining glycidol in an glycerine enema raw material. The glycidol in the glycerine enema raw material is determined mainly through a gas chromatography method; methanol is adopted as a solvent for a sample; and therefore, safety and high applicability can be realized; a sample treatment method is convenient and rapid; an analysis method is simple, convenient and rapid; the separation capacity is high; a quantitative result is accurate; the recovery rate is high; the detection limit is 0.32 ng which is equivalent to 0.00008% of test concentration; the quantification limit is 0.79 ng which is equivalent to 0.00020% of test concentration; the detection requirement that the limit of glycidol in ICH M7 is 0.002% is met; a glycerine enema raw material quality control standard is improved; and the safety of glycerine enema products (containing glycerol) is improved.

Description

technical field [0001] The invention relates to a method for determining glycidol in Kaisailu raw materials, in particular to a method for determining glycidol in Kaisailu raw materials by gas chromatography. Background technique [0002] Kaisailu English name: Glycerine Enema, which is divided into two preparations, one is glycerin preparations, the other is mannitol, magnesium sulfate preparations, of which Kaisailu (containing glycerin) is the most widely used, it is a laxative Non-prescription drugs, mainly used for the treatment of constipation in children and elderly infirm. It lubricates and stimulates the intestinal wall, softening the stool so it can pass easily. [0003] Glycerin (Glycerin, CAS No.: 56-81-5), also known as glycerin, molecular formula: C 3 h 8 o 3 , Glycerin is widely used in industries such as medicine, food, papermaking, cosmetics, tanning, photography, printing, metal processing, electrical materials and rubber. In medicine, it is used to pr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 雷秀峰汪海宣朱克旭程璐戴小华戴建
Owner FRONT PHARM PLC
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