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

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...

AI Technical Summary

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 repeated extraction with chloroform, after the extract is evaporated and concentrated, non-aqueous alkali Quantitative determination, this method is cumbersome and time-consuming, and the solvent is highly toxic, so special attention should be paid to labor protection issues during operation