High performance liquid detection method of dexamethasone

A technology of dexamethasone and high performance liquid phase, which is applied to measurement devices, instruments, scientific instruments, etc., can solve the problems of high quantitative lower limit of standard curve and long detection time, and achieves good linear relationship, short detection time and good separation effect. Effect

Inactive Publication Date: 2021-02-12
上海药明康德新药开发有限公司
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Problems solved by technology

[0006] It can be seen that regarding the quantitative detection of dexamethasone, the detection time of the existing method is relatively long, and the lower limit of quantification of the standard curve is relatively high

Method used

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  • High performance liquid detection method of dexamethasone
  • High performance liquid detection method of dexamethasone
  • High performance liquid detection method of dexamethasone

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Experimental program
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Effect test

Embodiment 1

[0064] The mobile phase A is an aqueous solution of trifluoroacetic acid, and the volume concentration of trifluoroacetic acid in the aqueous solution is 0.1%; the mobile phase B is an acetonitrile solution of trifluoroacetic acid, and the volume concentration of trifluoroacetic acid in the acetonitrile solution is 0.1%.

[0065] Through three injections under this method, the HPLC collection of spectra is as follows Figure 1-3 As shown, the baseline is stable, the repeatability is good, all the peaks can emerge in 3 minutes, the retention time of dexamethasone is 2.077-2.081 min, the retention time of process impurities is 0.821-0.829 min, and the separation is good.

Embodiment 2

[0067] Mobile phase A is an aqueous solution of trifluoroacetic acid, and the volume concentration of trifluoroacetic acid in the aqueous solution is 0.05%; mobile phase B is an acetonitrile solution of trifluoroacetic acid, and the volume concentration of trifluoroacetic acid in the acetonitrile solution is 0.05%.

[0068] Under this method, the baseline is slightly unstable, the retention time of dexamethasone is about 2.125min, and the resolution is good.

Embodiment 3

[0070] The mobile phase A is an aqueous solution of trifluoroacetic acid, and the volume concentration of trifluoroacetic acid in the aqueous solution is 0.2%; the mobile phase B is an acetonitrile solution of trifluoroacetic acid, and the volume concentration of trifluoroacetic acid in the acetonitrile solution is 0.2%.

[0071] Under this method, the baseline is stable, the retention time of dexamethasone is about 2.132min, some small miscellaneous peaks appear, and the resolution is good.

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Abstract

The invention discloses a high performance liquid detection method of dexamethasone, which adopts a reversed-phase C18 chromatographic column and a DAD detector, a mobile phase A is an aqueous solution of trifluoroacetic acid, a mobile phase B is an acetonitrile solution of trifluoroacetic acid, and gradient elution is adopted. By adopting the method disclosed by the invention to inject 3 to 5mu Lof samples, dexamethasone and related substances thereof can be effectively detected, the separation degree R can reach 1.5 or above, and an HPLC spectrum baseline is stable and free from drifting; the method is short in detection time, the high-performance liquid phase detection process can be completed within 3 min, the sample consumption is greatly reduced, meanwhile, the detection efficiencyis improved, and the method is suitable for high-throughput screening; the solvent can be saved and the cost is reduced; the method disclosed by the invention is used for measuring the content of dexamethasone, has a good linear relationship and high reproducibility, and has an important research value in the aspects of research on the quality of crude drugs and preparations, quantitative researchon related pharmacokinetics and the like.

Description

technical field [0001] The invention relates to the technical field of drug analysis, in particular to a high-efficiency liquid phase detection method for dexamethasone. Background technique [0002] Dexamethasone is a synthetic corticosteroid that was first synthesized in 1957 and listed in the World Health Organization's Model List of Essential Medicines, as one of the essential medicines for the basic public system. Like other glucocorticoids, it has pharmacological effects such as anti-inflammatory, anti-endotoxin, immunosuppressant, anti-shock and enhanced stress response, so it is widely used in various departments to treat various diseases, such as autoimmune diseases, allergies , Inflammation, asthma and dermatology, eye diseases. Dexamethasone sodium phosphate injection is an indispensable first-aid medicine for rescuing critically ill patients. For more than ten years, clinicians have used dexamethasone sodium phosphate to treat and prevent drug allergies caused b...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/74G01N30/34G01N30/86
CPCG01N30/02G01N30/34G01N30/74G01N30/8634G01N30/8641
Inventor 赵晓汤城
Owner 上海药明康德新药开发有限公司
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