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Method for detecting ganciclovir and related substances in ganciclovir ophthalmic gel

A detection method and technology for related substances, applied in the field of medicine, can solve problems such as incomplete separation and undetectable impurities, and achieve the effects of being conducive to detection and accurate quantification, good specificity, and improved separation.

Pending Publication Date: 2022-05-06
SHENYANG XINGQI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the difference in sample solvents and excipients, when this method is used to determine the related substances of ganciclovir ophthalmic gel, even in the case of removing the carbomer in ganciclovir ophthalmic gel, ganciclovir and the corresponding The resolution of the adjacent impurity (impurity E) is only 1.9, less than 2.0, not completely separated; and there may be undetectable impurities

Method used

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  • Method for detecting ganciclovir and related substances in ganciclovir ophthalmic gel
  • Method for detecting ganciclovir and related substances in ganciclovir ophthalmic gel
  • Method for detecting ganciclovir and related substances in ganciclovir ophthalmic gel

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0089] Example 1: Pre-processing research and verification of the test product preparation method

[0090] (1) Pre-processing research on the preparation of the test product

[0091] If the test product (i.e. the sample of ganciclovir ophthalmic gel to be tested) is directly diluted with mobile phase, the solution viscosity is high, it is difficult to filter, and it will lead to an increase in column pressure and a decrease in column efficiency. Carbomer must be effectively removed. followed by chromatographic analysis.

[0092]Adopt the method precipitation carbomer of 5% magnesium sulfate solution 4ml to add the sodium hydroxide solution 1ml of 0.1mol / L in the prior art: this method salt concentration is bigger, easily damages chromatographic column, is not suitable for HPLC method to measure, and because Due to the difference in preparation prescription and process, when this method is used to treat this product, the precipitate cannot be condensed, and the transfer an...

Embodiment 2

[0103] Example 2: Durability Study (1)

[0104] Instruments and conditions: Waterse 2695 liquid chromatography system, UV detector; Chromatographic column: Waters AtlantisT3 (5μm, 4.6mm×250mm); Detection wavelength: 252nm; Column temperature: 35°C; Flow rate: 1.0ml / min; Injection volume: 40 μl; mobile phase A is purified water, mobile phase B is methanol, and gradient elution is performed according to Table 2.

[0105] Table 2: Gradient elution parameters

[0106] time (minutes) Mobile phase A(%) Mobile phase B(%) 0 100 0 15 100 0 35 47 53 37 100 0 52 100 0

[0107] Experimental procedure: take an appropriate amount of ganciclovir reference substance, quantitatively dilute it with mobile phase A to make a solution containing about 0.15 mg per 1 ml, shake well, and use it as the ganciclovir reference substance solution; take another ganciclovir EP and mix One impurity reference substance was dissolved in 1ml of ganciclovir ref...

Embodiment 3

[0109] Example 3: Durability Study (2)

[0110] The instruments, chromatographic conditions and experimental procedures were the same as in Example 2, except that methanol-water (3:97) was used as mobile phase A.

[0111] The results show that the main component can be completely separated from adjacent impurities and each impurity, and the specificity is good.

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Abstract

The invention belongs to the field of medicines, and relates to a method for detecting a main component (ganciclovir) and / or related substances in ganciclovir ophthalmic gel. Specifically, the method comprises a step of removing carbomer in ganciclovir ophthalmic gel and a step of performing HPLC (High Performance Liquid Chromatography) analysis, and the detection method disclosed by the invention is high in specificity and stable in retention time of a chromatographic peak; according to the method for removing the carbomer from the sample, ganciclovir is good in solubility, the solution is stable, the carbomer can be effectively removed, a chromatographic column is not damaged, and the ganciclovir has a good application prospect.

Description

technical field [0001] The invention belongs to the field of medicine, and relates to a method for detecting main components (ganciclovir) and / or related substances in ganciclovir ophthalmic gel. The invention also relates to a quality control method for ganciclovir ophthalmic gel. Background technique [0002] Ganciclovir ophthalmic gel is a topical ophthalmic antiviral drug indicated for the treatment of acute herpetic keratitis. The drug was first approved in France in 1995 under the trade name Virgan. Since its initial approval, the drug has been approved in more than 30 countries. Ganciclovir ophthalmic gel uses water-soluble materials as the gel matrix, which has good biocompatibility and is less irritating. The gel can increase the contact time between the drug and the patient, prolong the time limit of drug action, and can improve early The patient's symptoms and shorten the course of the disease, and the safety and reliability, clinical application effect is good...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/14G01N30/16G01N30/60G01N30/30G01N30/32G01N30/34G01N30/74
CPCG01N30/02G01N30/06G01N30/14G01N30/16G01N30/60G01N30/30G01N30/32G01N30/34G01N30/74G01N2030/065G01N2030/324
Inventor 刘继东王芳杨强付乐孙洋
Owner SHENYANG XINGQI PHARM CO LTD
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