Method for analyzing composition of hydroxychloroquine sulfate preparation by high performance liquid chromatography

A high-performance liquid chromatography and hydroxychloroquine sulfate technology, applied in the field of medicine, can solve the problems of high solvent toxicity, labor protection, cumbersome and time-consuming methods, etc., and achieve the effects of high specificity, simple operation and high accuracy

Pending Publication Date: 2020-07-10
NANJING MEIRUI PHARMA CO LTD
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Problems solved by technology

[0003] The object of the present invention is to provide a method for analyzing the composition of hydroxychloroquine sulfate preparation with high performance liquid chromatography, to solve the problem that the existing assay method proposed in the above-mentioned background technology is

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[0016] In order to make the technical solutions of the present invention clearer and clearer to those skilled in the art, the present invention will be further described in detail below in conjunction with examples, but the embodiments of the present invention are not limited thereto.

[0017] A kind of method that the present embodiment provides analyzes the composition of hydroxychloroquine sulfate preparation with high performance liquid chromatography, and specific method is as follows:

[0018] Step a: Select 50mg of hydroxychloroquine sulfate reference substance, carry out precise weighing, then place it inside a 50ml volumetric flask, dissolve it with mobile phase and dilute to the mark, then fully shake it up for later use;

[0019] Step b: Precisely measure 1.0ml, 2.0ml, 3.0ml, 4.0ml, 5.0ml, 6.0ml and 7.0ml of the mixture in step a and place it in a 10ml volumetric flask, dissolve and dilute to the mark with mobile phase, then Shake well for later use;

[0020] Step ...

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Abstract

The invention discloses a method for analyzing a composition of a hydroxychloroquine sulfate preparation by high performance liquid chromatography. The method comprises the following steps: a. selecting 50mg of hydroxychloroquine sulfate reference substance, and precisely weighing; b, precisely weighing 1.0 ml, 2.0 ml, 3.0 ml, 4.0 ml, 5.0 ml, 6.0 ml and 7.0 ml of the mixed solutions obtained in the step a, and putting the mixed solutions into a 10ml volumetric flask for later use; c, performing chromatographic analysis by using a chromatographic column to obtain a regression equation of a concentration C and a peak area A; and d, removing a proper amount of a mixture obtained in the step a, precisely weighing, adding a diluent to dissolve, and quantitatively diluting to prepare a solutioncontaining 0.5 mg per 1ml to obtain a test solution; and precisely measuring the test solution, adding a mobile phase, diluting to prepare a solution containing 0.05 g per 1ml as a control solution, precisely measuring 0.2 ml of the control solution, injecting the control solution into a liquid chromatograph, and adjusting sensitivity of an instrument for testing. The method for analyzing the composition of the hydroxychloroquine sulfate preparation by the high performance liquid chromatography is simple and convenient to operate, sensitive, high in accuracy, suitable for clinical hydroxychloroquine serum drug concentration monitoring and high in specificity.

Description

technical field [0001] The invention relates to a method for analyzing the composition of a hydroxychloroquine sulfate preparation by using high performance liquid chromatography, and belongs to the technical field of medicine. Background technique [0002] Hydroxychloroquine sulfate is clinically used for rheumatoid arthritis, juvenile chronic arthritis, discoid and systemic lupus erythematosus, and skin lesions caused or aggravated by sunlight. Hydroxychloroquine has similar pharmacological effects, pharmacokinetics and metabolic processes in the body. After oral administration, hydroxychloroquine is rapidly and almost completely absorbed. In one study, after a single 400 mg dose of hydroxychloroquine was administered to healthy volunteers, the mean peak plasma concentrations ranged from 53 to 208 ng / ml, with a mean of 105 ng / ml. The average time to peak plasma concentration was 1.83 hours. Depending on the time after administration, the mean plasma elimination half-lif...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/36G01N30/74
CPCG01N30/02G01N30/06G01N30/34G01N30/36G01N30/74
Inventor 王先登毛逸飞
Owner NANJING MEIRUI PHARMA CO LTD
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