Prednisone is chemically named 11,17, 21-trihydroxyprogesterone 1, 4-diene-3, 20-dione, white or white-like crystalline powder;No odor, slightly bitter taste;There is moisture absorption.Dissolved in methanol or ethanol, slightly dissolved in acetone or dioxane, slightly dissolved in chloroform, very slightly dissolved in water.The molecular formula is C21H28O5, the molecular weight is 360.44400, the density is 1.31 g/cm3, the melting point is 240 °C (dec.)(lit.), and the boiling point is 570.6 C at 760 mmHg.

Identify:

(1) take 10mg of this product, add 1ml of methanol to dissolve it, add 1ml of alkaline copper tartrate test solution, and heat it to produce orange-red precipitation.

(2) take about 2mg of this product, add 2ml of sulfuric acid, gradually show deep red color, no fluorescence;Add 10ml water and the red color fades to form gray flocculent precipitate.

(3) in the chromatogram recorded under the content determination, the retention time of the main peak of the sample solution should be consistent with that of the control sample solution.

(4) the infrared absorption spectrum of the product shall be consistent with that of the control group.

Content determination:

It was determined by high performance liquid chromatography.

Chromatographic conditions and system suitability test

Using octadecylsilane bonded silica gel as filler;The mobile phase was methanol-water (65:35).The detection wavelength is 240nm.The theoretical plate number should be no less than 1000 according to prednisone peak, and the separation degree between prednisone peak and internal standard material peak should be greater than 3.5.

Preparation of internal standard solution:

Norethindrone was dissolved in methanol and diluted to a solution containing approximately 1.5mg per 1ml.

Measurement:

Take this product, accurately weigh it, dissolve it with methanol and dilute it quantitatively to make a solution containing about 1mg per 1ml;The solution and the internal standard solution were measured with a precision of 5ml each, placed in a 50ml measuring bottle, diluted with methanol to the scale, shaken well, and then injected into the liquid chromatograph with 10l to record the chromatographic chart.Prednisone was also taken as a reference and determined by the same method.The peak area is calculated according to the internal standard method.

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