Method for determining content of guanine in ganciclovir

A determination method, guanine technology, applied in measuring devices, instruments, scientific instruments, etc., can solve the problem of incomplete separation of ganciclovir and guanine

Inactive Publication Date: 2019-10-22
武汉长联来福制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] In order to solve the above problems, the present invention provides a simple, sensitive and rapid detection method, which overcomes the problem that ganciclovir and guanine cannot be completely separated

Method used

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  • Method for determining content of guanine in ganciclovir
  • Method for determining content of guanine in ganciclovir
  • Method for determining content of guanine in ganciclovir

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Embodiment 1: one of guanine content assay methods in ganciclovir:

[0028] 1. Experimental equipment and chromatographic conditions

[0029] Shimadzu liquid chromatograph, CHIRALCEL OJ-H chromatographic column (4.6*200mm, 5μm), with n-hexane-isopropanol (80:20) as mobile phase, isocratic elution, flow rate 1.0ml / min, The column temperature is 30° C., the measurement wavelength is 252 nm, and the injection volume is 10 μl.

[0030] 2. Determination of samples

[0031] Accurately weigh an appropriate amount of guanine reference substance, and use mobile phase to prepare a solution containing 5 μg of guanine per 1 ml as the reference solution; accurately weigh an appropriate amount of ganciclovir, and use mobile phase to prepare a solution containing ganciclovir per 1 ml Wei 5mg solution, as the test solution. According to the chromatographic conditions under the guanine content determination item in ganciclovir, each 10 μ l of need testing solution and reference solut...

Embodiment 2

[0032] Embodiment 2: two of guanine content assay methods in ganciclovir:

[0033] 1. Experimental equipment and chromatographic conditions

[0034] Shimadzu liquid chromatograph, CHIRALCEL OJ-H chromatographic column (4.6*200mm, 5μm), using n-hexane-isopropanol (90:10) as mobile phase, for isocratic elution, flow rate 1ml / min, column The temperature is 30°C, the measurement wavelength is 252nm, and the injection volume is 10μl.

[0035] 2. Determination of samples

[0036] Accurately weigh an appropriate amount of guanine reference substance, and use mobile phase to prepare a solution containing 5 μg of guanine per 1 ml as the reference solution; accurately weigh an appropriate amount of ganciclovir, and use mobile phase to prepare a solution containing ganciclox per 1 ml Wei 5mg solution, as the test solution. According to the chromatographic conditions under the guanine content determination item in ganciclovir, each 10 μ l of need testing solution and reference solution...

Embodiment 3

[0037] Embodiment 3: three of guanine content assay methods in ganciclovir:

[0038] 1. Experimental equipment and chromatographic conditions

[0039] Shimadzu liquid chromatograph, CHIRALCEL OJ-H chromatographic column (4.6*200mm, 5μm), with n-hexane-isopropanol (70:30) as mobile phase, isocratic elution, flow rate 1.0ml / min, The column temperature is 30° C., the measurement wavelength is 252 nm, and the injection volume is 10 μl.

[0040] 2. Determination of samples

[0041] Accurately weigh an appropriate amount of guanine reference substance, and use mobile phase to prepare a solution containing 5 μg of guanine per 1 ml as the reference solution; accurately weigh an appropriate amount of ganciclovir, and use mobile phase to prepare a solution containing ganciclox per 1 ml Wei 5mg solution, as the test solution. According to the chromatographic conditions under the guanine content determination item in ganciclovir, each 10 μ l of the need testing solution and the referen...

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Abstract

The invention discloses a method for determining content of guanine in ganciclovir, which belongs to the technical field of drug analysis and detection, and adopts a high-performance liquid chromatography as the detection method. The invention provides a normal phase detection method, which enables the guanine to have good peak shapes in a liquid chromatographic column and being able to be completely separated from ganciclovir for facilitating quantitative analysis. The method is characterized by comprising the steps of: taking n-hexane-isopropanol as a mobile phase; adopting cellulose-tris (4-methylphenyl formate) silica gel as a filler; taking the n-hexane- isopropanol (80:20) as the mobile phase, wherein the flow rate is 0.8-1.5 ml / min, the column temperature is 25-35 DEG C, the detection wavelength is 252 nm and a sample injection quantity is 10 mu L; and waiting for elution. The method of the invention is simple, reliable and high in sensitivity, has good resolution and reproducibility, is precise and reliable in result, and can be used for controlling the content of guanine in ganciclovir.

Description

technical field [0001] The invention belongs to the technical field of drug analysis and determination, in particular to a method for determining the content of guanine in ganciclovir. Background technique [0002] Ganciclovir (Ganciclovir, GCV, DHPG) is an anti-herpes virus cyclic guanosine analog approved by Syntex Corporation of the United States in 1988. It is first phosphorylated into a triphosphate activator in the body, competing Sexually inhibit DNA polymerase, so that the extension of viral DNA is terminated, and its inhibitory effect on cytomegalovirus (CMW) is 50 times stronger than that of acyclovir. It is a drug commonly used to treat cytomegalovirus infection. It has a good preventive effect on those cytomegaloviruses that may occur in organ transplant recipients who are at risk of cytomegalovirus infection. Its chemical structure is: [0003] [0004] Ganciclovir [0005] In the synthesis process of ganciclovir, guanine is used as the main raw material, w...

Claims

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/027
Inventor 万梦郭文胜刘大鹏赵秀林
Owner 武汉长联来福制药股份有限公司
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