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Detection method and application of related substances in hydroxypropyl-beta-cyclodextrin

A technology of beta-cyclodextrin and related substances, applied in the field of analytical chemistry, can solve the problems of poor reproducibility of analytical methods, inability to guarantee quantitative accuracy, etc., and achieve the effect of good durability

Pending Publication Date: 2022-04-15
LI MIN PHARM FAB OF LIVZON PHARM GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, the above analysis methods have poor reproducibility and cannot guarantee the quantitative accuracy of the test product in the process of continuous sample injection.

Method used

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  • Detection method and application of related substances in hydroxypropyl-beta-cyclodextrin
  • Detection method and application of related substances in hydroxypropyl-beta-cyclodextrin
  • Detection method and application of related substances in hydroxypropyl-beta-cyclodextrin

Examples

Experimental program
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Effect test

Embodiment 1

[0068] The column temperature is 40°C, the detector temperature is 40°C, the injection volume is 20 μl, the mobile phase A: water, the mobile phase B: methanol, the total flow rate of the mobile phase is constant at 1.5ml / min, and the elution procedure is as follows:

[0069] 0min~15min, mobile phase A;

[0070] 15min~16min, the volume fraction of mobile phase A in mobile phase A and mobile phase B drops from 100% to 30%;

[0071] From 16min to 21min, the volume fraction of mobile phase A in mobile phase A and mobile phase B is maintained at 30%;

[0072] From 21min to 22min, the volume fraction of mobile phase A in mobile phase A and mobile phase B increases from 30% to 100%;

[0073] 22min~100min, mobile phase A.

[0074] existing method

[0075] The method of "Chinese Pharmacopoeia" 2020 edition, the column temperature is 40°C, the detector temperature is 40°C, water is the mobile phase, the flow rate is 1.5ml / min, and the injection volume is 20μl.

[0076] System suita...

Embodiment 2

[0150] The elution procedure is as follows, and except the elution procedure, other chromatographic detection conditions are all the same as in Example 1:

[0151] 0min~15min, mobile phase A;

[0152] 15min~16min, the volume fraction of mobile phase A in mobile phase A and mobile phase B decreased from 100% to 60%;

[0153] From 16min to 21min, the volume fraction of mobile phase A in mobile phase A and mobile phase B is maintained at 60%;

[0154] From 21min to 22min, the volume fraction of mobile phase A in mobile phase A and mobile phase B increases from 60% to 100%;

[0155] 22min~100min, mobile phase A.

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Abstract

The invention provides a detection method and application of related substances in hydroxypropyl beta-cyclodextrin, the related substances comprise 1, 2-propylene glycol and beta-cyclodextrin, liquid chromatography is adopted for detection, and the conditions are as follows: a phenyl bonded silica gel chromatographic column; a mobile phase A is water; the mobile phase B is methanol or acetonitrile; an elution procedure: eluting for at least 15 minutes by using the mobile phase A; switching the mobile phase, so that the volume fraction of the mobile phase A in the mobile phase A and the mobile phase B is reduced from 100% to 0-60%; maintaining elution of the switched mobile phase for a period of time; switching the mobile phase, so that the volume fraction of the mobile phase A in the mobile phase A and the mobile phase B is increased from 0-60% to 100%; and maintaining the mobile phase A to elute for a period of time. The method is good in specificity, applicability, accuracy, precision and durability and good in repeatability, and solves the problem that the related substances in the hydroxypropyl-beta-cyclodextrin are difficult to accurately detect under a continuous sample injection condition in the existing method.

Description

technical field [0001] The invention belongs to the technical field of analytical chemistry, and in particular relates to a detection method and application of related substances in hydroxypropyl beta cyclodextrin. Background technique [0002] Hydroxypropyl beta-cyclodextrin (that is, hydroxypropyl-β-cyclodextrin, hydroxypropyl-p-cyclodextrin, referred to as HP-B-CD) is a class formed by condensation of β-cyclodextrin and propylene oxide Hydroxyalkylated hydrophilic derivatives are a common pharmaceutical excipient. Various impurities may be introduced during the synthesis of hydroxypropyl beta cyclodextrin, including 1,2-propanediol and beta cyclodextrin. Impurity residues are directly related to drug safety, so it is necessary to strictly control the impurity content of hydroxypropyl beta cyclodextrin. [0003] Chromatography is a common method for detecting 1,2-propanediol and beta-cyclodextrin in hydroxypropyl-beta-cyclodextrin. In order to achieve accurate quantifica...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/30G01N30/32G01N30/34G01N30/74G01N30/86
Inventor 杜冠峰龙武辉赖莹莹刘亮峰黄文华
Owner LI MIN PHARM FAB OF LIVZON PHARM GRP
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