Ganciclovir related substance detection method

A detection method and related substance technology, applied in the field of detection of ganciclovir related substances, can solve problems such as failure to meet quality control requirements, unsatisfactory separation effect, inability to effectively separate various related substances, and achieve stable baseline and peak Beautiful shape, efficient qualitative and quantitative effects

Active Publication Date: 2021-12-24
HAINAN LEVTEC PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, the inventors used these two methods to detect related substances in ganciclovir, and found that the separation effect was not satisfactory, and the various related substances in ganciclovir could not be effectively separated, which could not meet the increasing demands of the industry. Quality Control Requirements

Method used

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  • Ganciclovir related substance detection method
  • Ganciclovir related substance detection method
  • Ganciclovir related substance detection method

Examples

Experimental program
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Effect test

Embodiment 1

[0066] Chromatographic column: T3 column ( T3, 4.6*250mm 5μm);

[0067] Wavelength: 252nm; Column temperature: 30°C, Flow rate: 1.0mL / min;

[0068] Mobile phase: Mobile phase A is: 0.012mol / L ammonium dihydrogen phosphate solution (adjust the pH value to 3.0 with phosphoric acid)-methanol (97:3), and mobile phase B is: methanol;

[0069] Sample solution: same as Comparative Example 1. Precisely measure 20 μL of the sample solution, inject it into a liquid chromatograph for analysis, and record the test results. The elution program is shown in Table 4. Test results such as Figure 7 shown. Figure 7 Among them, peak No. 3 is the main peak, and peaks No. 1-2 and No. 4-11 are related substance peaks. Using the detection method of the present invention, 10 related substances can be detected at the same time within 60 minutes, and the No. 3 main peak and No. 4 related substance peaks achieve baseline separation, the overall baseline is stable, the peak shape is good, and the...

Embodiment 2

[0071] The durability test conditions are as follows:

[0072] Column temperature change: the chromatographic conditions provided in Example 1 were changed by ±5°C based on the column temperature of 25°C, namely 25°C and 35°C.

[0073] Flow rate change: on the basis of the chromatographic condition flow rate 1.0mL / min provided in Example 1, change ±0.1mL / min, namely 0.9mL / min and 1.1mL / min.

[0074] Mobile phase pH change: change ± 0.2 on the basis of the chromatographic condition pH3.0 that provides in embodiment 1, i.e. pH2.8 and pH3.2

[0075] Need testing solution: Accurately weigh 150 mg of ganciclovir (Hubei Gedian Renfu Pharmaceutical Co., Ltd., batch number: F-GXL190101) in a 50 mL measuring bottle, add 1 mL of 0.6 mol / L sodium hydroxide solution to dissolve, and dissolve with water Dilute to the mark, shake well, accurately measure an appropriate amount, and dilute with water to make a solution containing about 0.3mg per 1mL.

[0076] Control solution: Precisely pip...

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Abstract

The invention discloses a ganciclovir related substance detection method, and relates to the field of pharmaceutical analysis. According to the ganciclovir related substance detection method, an octadecyl silane bonded silica gel chromatographic column is used, 0.012 mol / L ammonium dihydrogen phosphate solution-methanol (98-95: 2-5, V / V) is used as a mobile phase A, methanol is used as a mobile phase B, gradient elution is carried out, and the related substances in ganciclovir are detected. The pH value of the ammonium dihydrogen phosphate solution is adjusted to 2.5-3.5 by using a phosphoric acid solution. The method can be used for rapidly and effectively separating various potential trace related substances in ganciclovir raw material medicines, has the advantages of stable base line, attractive peak shape, good separation degree between a main peak and adjacent impurities and between the adjacent impurities, high durability and the like, and can be used for efficiently realizing qualitative and quantitative treatment of various related substances in ganciclovir. The method is suitable for rapid quality monitoring of ganciclovir in industrial mass production, and has important significance for product quality control.

Description

technical field [0001] The invention relates to the field of drug analysis, in particular to a method for detecting ganciclovir related substances. Background technique [0002] Ganciclovir (Ganciclovir), chemical name is: 9-(1,3-dihydroxy-2-propoxymethyl)-guanine, is a kind of antiviral drug with high efficiency, low toxicity, strong selectivity, to All six kinds of herpes virus infection in human body have a strong inhibitory effect, and it is used for the treatment and prevention of cytomegalovirus infection in immunodeficiency patients and organ transplant recipients. [0003] Drugs will introduce related substances in the process of production and / or storage, and these related substances will affect the stability and safety of drugs to varying degrees. Therefore, the inspection of drug-related substances is also a very important link to control the purity of drugs and improve the quality of drugs . In the 2015 edition of Chinese Pharmacopoeia, use high performance liq...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/86
CPCG01N30/02G01N30/06G01N30/8679G01N2030/065Y02A50/30
Inventor 黄琴陈焕海吉家玉童庆国刘争光黄浩喜苏忠海
Owner HAINAN LEVTEC PHARMA
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