A kind of assay method of tetracaine hydrochloride related substances

A technique for tetracaine hydrochloride and its determination method, which is applied in the field of determination of tetracaine hydrochloride raw materials and related substances in preparations, and can solve problems such as tumors and DNA destructiveness

Active Publication Date: 2020-08-25
JIANGSU JIUXU PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Genotoxic substances are potentially damaging to DNA at any ingested level, and this damage may lead to tumor development

Method used

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  • A kind of assay method of tetracaine hydrochloride related substances
  • A kind of assay method of tetracaine hydrochloride related substances
  • A kind of assay method of tetracaine hydrochloride related substances

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Example 1 related verification

[0037] Limit of detection, limit of quantitation:

[0038] Preparation of tetracaine hydrochloride detection limit solution: Accurately weigh 27.02mg of tetracaine hydrochloride standard substance, put it in a 50ml measuring bottle, add 20% acetonitrile solution to dissolve and dilute to the scale, accurately measure 0.4ml, put it in 50ml volume In the bottle, add 20% acetonitrile solution to dilute to the mark, accurately measure 0.5ml, put it in a 10ml measuring bottle, add 20% acetonitrile solution to dilute to the mark, accurately measure 3ml, put it in a 10ml measuring bottle, add 20% After the acetonitrile solution was diluted to the mark, the signal-to-noise ratio was 3.4.

[0039] The preparation of p-aminobenzoic acid quantitative limit and detection limit solution: accurately weigh 25.70 mg (purity 99.8%) of p-aminobenzoic acid standard substance, put it in a 100ml measuring bottle, add 20% acetonitrile solution to dissolve an...

Embodiment 2

[0068] Embodiment 2 Forced destruction test

[0069] Prepare need testing solution by following method, then carry out HPLC detection by the method of the present invention and International Pharmacopoeia (USP, EP, BP) method respectively, the results see Figure 1-Figure 8 . The results showed that 2 impurities could be detected in the test solution which was not destroyed by the international pharmacopoeia method; 5 impurities could be detected by oxygen destruction, and the main peak was not completely separated from the adjacent peaks.

[0070] 1. Undamaged: Take 10mg of tetracaine hydrochloride, put it in a 10ml measuring bottle, add 20% acetonitrile to dilute to the mark.

[0071] According to the test results of the International Pharmacopoeia, see figure 1 , according to the detection result of the method of the present invention see image 3 .

[0072] 2. Acid destruction: Take 10mg of tetracaine hydrochloride, put it in a 10ml measuring bottle, add 0.5ml of 0.5mo...

Embodiment 3

[0082] Embodiment 3 method comparison

[0083]

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PUM

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Abstract

The invention relates to a method for measuring related matters of tetracaine hydrochloride. The method adopts the following HPLC (high performance liquid chromatography) detection conditions that octadecylsilane chemically bonded silica is used as a filling agent (4.6mm*150mm, 5mu m); acetonitrile-water-triethylamine is used as a fluid phase A; methanol-acetonitrile-water-triethylamine is used asa fluid phase B, and the gradient elution is performed. The method has the advantages that the operation is simple and convenient, and is quick and accurate; the related matters of the tetracaine hydrochloride can be detected, and the quality of a product can be truly reflected.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, and in particular relates to a method for determining related substances of tetracaine hydrochloride raw materials and preparations. Background technique [0002] Tetracaine hydrochloride is a commonly used local anesthetic with strong penetrating power and good diffusivity, and can penetrate mucous membranes. It is mainly used for mucous membrane anesthesia. It acts quickly and takes effect quickly, but it has certain toxic and side effects. The molecular structure of tetracaine hydrochloride has a genotoxicity warning structure, although the clinical application of tetracaine hydrochloride has a long history and safety is guaranteed. However, its related impurities also have a genotoxic warning structure, and the safety of its impurities has not been reported clinically. Genotoxic impurities can directly or indirectly damage cellular DNA, resulting in mutagenic and carcinogenic effects. ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 陈沛单于自勋陈应林毛黎静吴杰
Owner JIANGSU JIUXU PHARMA
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