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Detection method of related substances of dantrolin sodium and quality control method of dantrolin sodium

A related substance, the technology of dantrolene sodium, which is applied in the detection field of dantrolene sodium, can solve the problems of inability to separate the baseline, achieve good product quality, and improve the effect of low detection sensitivity

Pending Publication Date: 2022-05-13
LIVZON PHARM GRP INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

This patented technology allows for accurate measurement of certain chemicals called diindoline or indolinone that are commonly used during manufacturing processes such as pharmaceuticals. By measuring these compounds without being able to distinguish between them correctly, this helps prevent issues with lowered accuracy and reduced reliability associated therewith.

Problems solved by technology

This patented technical problem addressed in this patents relates to improving the purity level (quality control), stability during manufacturing processes or long term use of danrolol hydrochloride tablets containing these compounds due to their potential negative effects on human health caused by excessive levels of certain ingredients like beta blockers and other drugs commonly prescribed together called statins.

Method used

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  • Detection method of related substances of dantrolin sodium and quality control method of dantrolin sodium
  • Detection method of related substances of dantrolin sodium and quality control method of dantrolin sodium
  • Detection method of related substances of dantrolin sodium and quality control method of dantrolin sodium

Examples

Experimental program
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Effect test

Embodiment 1

[0076] The present embodiment provides a kind of detection method of the related substance of dantrolene sodium, it comprises the steps:

[0077] S1, solution preparation.

[0078] (1) Impurity B reference substance stock solution: Accurately weigh about 8.0 mg of impurity B reference substance, put it in a 20ml measuring bottle, add 3ml DMF to dissolve, add 3ml glacial acetic acid, dilute to the mark with acetone, shake well, and use it as the impurity B control stock solution.

[0079] (2) Dantrolene reference substance stock solution: Accurately weigh about 8.0 mg of dantrolene reference substance, put it in a 20ml measuring bottle, add 3ml of DMF to dissolve, add 3ml of glacial acetic acid, add acetone to dilute to the mark, shake well, and use as dantrolene Forest control substance stock solution.

[0080] (3) Related substance reference substance solution: precisely pipette 5ml of dantrolene reference substance stock solution and place in a 200ml measuring bottle, dilu...

Embodiment 2

[0088] This example provides a method for detecting related substances of dantrolene sodium, which is basically the same as Example 1, except that the elution procedure is different.

[0089] The elution procedure of the present embodiment is as follows:

[0090] time (min) Mobile phase A(%) Mobile phase B(%) Mobile phase C(%) 0 75 0 25 3 60 0 40 4 65 0 35 5 85 0 15 7 0 70 30 10 0 35 65 11 75 0 25 20 75 0 15

Embodiment 3

[0092] This example provides a method for detecting related substances of dantrolene sodium, which is basically the same as Example 1, except that the elution procedure is different.

[0093] The elution procedure of the present embodiment is as follows:

[0094] time (min) Mobile phase A(%) Mobile phase B(%) Mobile phase C(%) 0 82 0 18 3 67 0 33 4 72 0 28 5 92 0 8 7 0 77 23 10 0 42 58 11 82 0 18 20 82 0 18

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Abstract

The invention discloses a detection method of related substances of dantrolin sodium and a quality control method of the dantrolin sodium, and relates to the technical field of detection of the dantrolin sodium. The detection method comprises the following steps: analyzing a related substance test solution containing dantrolin sodium by adopting a high performance liquid chromatography, and specifically, carrying out specific gradient elution by adopting a three-phase mobile phase, so that the separation degree among impurities can be effectively improved. The detection method not only can accurately quantify the known degradation impurity B, but also can accurately quantify the content of unknown impurities, and ensures that the product is better in quality and safer.

Description

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Claims

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Application Information

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Owner LIVZON PHARM GRP INC
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