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.