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Method for detecting multiple components in mixed solution

A detection method and multi-component technology, which is applied in the field of detection and chemical analysis and detection, can solve the problems of low analysis efficiency of lactic acid excipients, achieve good separation, improve clarity and accuracy, and improve detection and analysis efficiency

Active Publication Date: 2020-04-10
SICHUAN HUIYU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0005] The purpose of the present invention is to overcome the above-mentioned shortcomings of the low efficiency of the analysis of lactic acid excipients in the prior art, and provide a multi-component detection method in the mixed solution, which can detect and analyze lactic acid and its polymers at the same time, and can significantly increase the concentration of lactic acid. Detection and Analysis Efficiency and Quality Control Capability of Pharmaceutical Lactic Acid Excipients

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  • Method for detecting multiple components in mixed solution
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  • Method for detecting multiple components in mixed solution

Examples

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Embodiment 1

[0044] The multi-component detection method in the mixed solution of embodiment 1 may further comprise the steps:

[0045] 1) Preparation of blank solvent: weigh 4g of tetramethylammonium hydroxide pentahydrate, add 900ml of water, dissolve, adjust the pH to 2.0 with phosphoric acid, add 100ml of acetonitrile, and mix well;

[0046] 2) Preparation of test solution: get 30 mg of lactic acid solution, dissolve and dilute with 10 ml of solvent to make 3 mg / ml test solution;

[0047] 3) Detection: Precisely measure 10 μL of the test solution obtained in step 2, inject it into a liquid chromatograph, record the chromatogram under the condition of a UV detector wavelength of 210 nm, and count the retention time, tailing factor, number of theoretical plates and resolution and other indicators.

[0048] Chromatographic column: octadecyl bonded silica gel (YMC-Pack ODS-AQ C18 (4.6mm×250mm, 5μm), the same below);

[0049] Mobile phase A: Weigh 4g of tetramethylammonium hydroxide penta...

Embodiment 2

[0061] The multi-component detection method in the mixed solution of embodiment 2 comprises the following steps:

[0062] 1) Preparation of blank solvent: weigh 10g of tetramethylammonium hydroxide pentahydrate, add 950ml of water, dissolve, adjust the pH to 2.0 with phosphoric acid, add 50ml of acetonitrile, and mix well;

[0063] 2) Preparation of test solution: get 30 mg of lactic acid solution, dissolve and dilute with 10 ml of solvent to make 3 mg / ml test solution;

[0064] 3) Detection: Precisely measure 10 μL of the test solution obtained in step 2, inject it into a liquid chromatograph, record the chromatogram under the condition of a UV detector wavelength of 210 nm, and count the retention time, tailing factor, number of theoretical plates and resolution and other indicators.

[0065] Chromatographic column: octadecyl bonded silica gel;

[0066] Mobile phase A: Weigh 10g of tetramethylammonium hydroxide pentahydrate, add 950ml of water, dissolve, adjust the pH to 2...

Embodiment 3

[0079] The detection method capable of simultaneously detecting multiple components in the mixed solution of embodiment 3 comprises the following steps:

[0080] 1) Preparation of blank solvent: weigh 1g of tetramethylammonium hydroxide pentahydrate, add 800ml of water, dissolve, adjust the pH to 2.0 with phosphoric acid, add 200ml of acetonitrile, and mix well;

[0081] 2) Preparation of test solution: get 30 mg of lactic acid solution, dissolve and dilute with 10 ml of solvent to make 3 mg / ml test solution;

[0082] 3) Detection: Precisely measure 10 μL of the test solution obtained in step 2, inject it into a liquid chromatograph, record the chromatogram under the condition of a UV detector wavelength of 210 nm, and count the retention time, tailing factor, number of theoretical plates and resolution and other indicators.

[0083] Chromatographic column: octadecyl bonded silica gel;

[0084] Mobile phase A: Weigh 1g of tetramethylammonium hydroxide pentahydrate, add 800ml...

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Abstract

The invention discloses a method for detecting multiple components in a mixed solution, which comprises the following steps: (1) dissolving a test sample with a solvent to obtain a test sample solution; (2) the test solution passing through a reversed-phase liquid chromatographic column for separation and analysis; wherein the reversed-phase liquid chromatographic column adopts a mixed solution ofan alkaline ion pair reagent, a polar solvent and a medium polar solvent as a mobile phase, and the polar solvent and the medium polar solvent can be mutually dissolved; wherein the multi-component comprises a monomer of an organic acid and a polycondensate of the monomer; wherein themonomer of the organic acid contains hydroxyl. According to the detection method, lactic acid and polymers thereofcan be detected and analyzed at the same time, and the lactic acid detection and analysis efficiency and the quality control capacity of the drug lactic acid auxiliary materials can be remarkably improved.

Description

technical field [0001] The invention relates to a detection method, in particular to a multi-component detection method in a mixed liquid, and belongs to the technical field of chemical analysis and detection. Background technique [0002] Lactic acid, also known as 2-hydroxypropionic acid, has the molecular formula C 3 h 6 o 3 , is a hydroxyl-containing carboxylic acid compound. Lactic acid plays a role in various biochemical processes and is often used as an excipient in the pharmaceutical industry. When the concentration of lactic acid is greater than 80%, natural polymerization will occur, resulting in multimer polymers such as L-lactide, dimer, trimer and tetramer, forming a mixture of lactic acid and its condensates. The typical structures of lactic acid and its polymers are as follows. [0003] [0004] With the increase of the molecular weight of lactic acid polymers, lactic acid polymers may produce adverse reactions in the body of patients taking medication...

Claims

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Application Information

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IPC IPC(8): G01N30/88
CPCG01N30/88G01N2030/884
Inventor 杨仁明孙智
Owner SICHUAN HUIYU PHARMA
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