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Quality standard of dexamethasone sodium phosphate injection and detection method thereof

A technology of dexamethasone sodium phosphate and quality standards, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of not being able to represent product quality well, and achieve the effect of improving control and strong specificity

Inactive Publication Date: 2019-12-17
武汉久安药业有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The amount of nicotinamide added in dexamethasone sodium phosphate injection is about three times that of the main component dexamethasone sodium phosphate, but the original quality standard only measures the content of dexamethasone sodium phosphate in the injection, and the content of dexamethasone sodium phosphate Sodium content is not a good indicator of product quality

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  • Quality standard of dexamethasone sodium phosphate injection and detection method thereof
  • Quality standard of dexamethasone sodium phosphate injection and detection method thereof
  • Quality standard of dexamethasone sodium phosphate injection and detection method thereof

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Embodiment Construction

[0019] In order to make the purpose, technical solution and advantages of the present invention clearer, the embodiments of the present invention will be further described below in conjunction with the accompanying drawings.

[0020] In the following examples:

[0021] The setting conditions of the liquid chromatograph are: use octadecylsilane bonded silica gel as filler; use methanol-0.005M (M represents mol / l) sodium heptanesulfonate solution as mobile phase, methanol and heptanesulfonic acid The volume ratio of the sodium solution is 30:70; the detection wavelength is 262nm; the flow rate is 1.0ml / min; the column temperature is 30°C.

[0022] Instruments and reagents: Diana U-3000 high performance liquid chromatography; American Agilent high performance liquid chromatography; VWD variable wavelength ultraviolet detector; intelligent column thermostat; column: Thermo C18 150×4.6mm.

[0023] Niacinamide reference substance: purchased from the China Inspection Institute; niac...

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Abstract

The invention provides a quality standard detection method of a dexamethasone sodium phosphate injection. The quality standard detection method comprises the steps of: preparing a reference substancesolution, namely, weighing a nicotinamide reference substance, and adding water to dissolve the nicotinamide reference substance to prepare a nicotinamide reference substance solution; preparing a test sample solution, namely, measuring the dexamethasone sodium phosphate injection to be detected, and adding water to dissolve the dexamethasone sodium phosphate injection to prepare a nicotinamide test sample solution; preparing a system suitability solution, namely, measuring the dexamethasone sodium phosphate injection, and adding water to dilute the dexamethasone sodium phosphate injection toprepare a solution A; weighing a nicotinic acid reference substance, and adding water to dissolve the nicotinic acid reference substance to prepare a solution B; respectively measuring the solution Aand the solution B, and adding water to dilute the solution A and the solution B, so as to prepare a mixed solution containing nicotinic acid and nicotinamide; and injecting the prepared mixed solution into a liquid chromatograph for detection, respectively weighing the nicotinamide reference substance solution and the nicotinamide test sample solution and injecting them into the liquid chromatograph for detection if a separation degree of nicotinamide and nicotinic acid is not less than 3.0 and a number of theoretical plates calculated according to nicotinamide is not less than 2000, so as toobtain content of nicotinamide in the nicotinamide test sample solution.

Description

technical field [0001] The invention relates to the technical field of chemical drug injections, in particular to a quality standard for dexamethasone sodium phosphate injection and a detection method thereof. Background technique [0002] Dexamethasone sodium phosphate belongs to glucocorticoid drugs. It is white or slightly yellow powder, odorless, slightly bitter, easy to absorb moisture, easily soluble in water, and insoluble in chloroform, ether, and acetone. Dexamethasone Sodium Phosphate Injection is an injection, which is a common drug, and it is a white clear solution. It is mainly used for the treatment of allergic and autoimmune inflammatory diseases, and is mostly used for connective tissue diseases, active rheumatism, and rheumatoid joints. Inflammation, lupus erythematosus, severe bronchial asthma, severe dermatitis, ulcerative colitis, acute leukemia, etc. It is also used in the comprehensive treatment of certain severe infections, poisoning, and malignant lym...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/74
CPCG01N30/02G01N30/06G01N30/74
Inventor 何凯峰祝丽敏江坤张念
Owner 武汉久安药业有限公司
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