What Is Hydrocortisone Butyrate?

This product is white or almost white crystalline powder; odorless. This product is easily soluble in chloroform, soluble in methanol, slightly soluble in anhydrous ethanol, very slightly soluble in ether, and almost insoluble in water. Melting point The melting point of this product (Appendix VI C) is 197 to 208 ° C. It decomposes simultaneously when melting, and the melting distance must not exceed 4 ° C. Take the product with specific rotation, weigh it accurately, dissolve with chloroform and dilute it quantitatively to make a solution containing 10mg per 1ml, and measure it according to law (Appendix VI E). The specific rotation is + 47 ° to + 54 °.

Hydrocortisone butyrate

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This product is white or almost white crystalline powder; odorless. This product is in chloroform

[Category]: Dermatological Drugs

[MF MW] C25H36O6432.55

[Indications] Eczema, Dermatitis,

[Character]

Boiling point: 585.6 ° Cat760mmHg

Refractive index: 1.564

Flash point: 194 ° C

Inchi: InChI = 1 / C25H36O6 / c1-4-5-21 (30) 31-25 (20 (29) 14-26) 11-9-18-17-7-6-15-12-16 (27) 8-10-23 (15,2) 22 (17) 19 (28) 13-24 (18,25) 3 / h12,17-19,22,26,28H, 4-11,13-14H2,1- 3H3 / t17-, 18-, 19-, 22 +, 23-, 24-, 25- / m0 / s1

Density: 1.23g / cm3

[Identification]

Take about 4mg of this product, add 2ml of sulfuric acid to dissolve, that is yellow to brownish yellow, with green fluorescence. Take about 10mg of this product, add 1ml of methanol to dissolve, add

According to high performance liquid chromatography (Appendix VD). Chromatographic conditions and system suitability tests use octadecylsilane bonded silica as a filler, water-acetonitrile-glacial acetic acid (55: 45: 0.5) as the mobile phase; the detection wavelength is 240nm. The number of theoretical plates calculated from the peak of hydrocortisone butyrate should not be less than 1500, and the resolution between the peak of hydrocortisone butyrate and the peak of the internal standard substance should meet the requirements. Preparation of the internal standard solution: Take an appropriate amount of methyltestosterone, add methanol to make a solution containing 0.18mg per 1ml, and obtain it. The test method is to take an appropriate amount of the hydrocortisone butyrate reference, accurately weigh it, add methanol to dissolve and quantitatively dilute it to make a solution containing about 0.26mg per 1ml; precisely measure 5ml each of this solution and the internal standard solution, and set the amount to 50ml In the bottle, add methanol to dilute to the mark, shake well, take 20l into the liquid chromatograph, record the chromatogram, take another appropriate amount of the product, measure the same method, and calculate the peak area according to the internal standard method.

Method name:

Hydrocortisone Butyrate API-Hydrocortisone Butyrate-High Performance Liquid Chromatography

Application:

This method uses high performance liquid chromatography to determine the content of hydrocortisone butyrate in the hydrocortisone butyrate drug substance.

This method is suitable for hydrocortisone butyrate drug substance.

Method principle:

The test product was dissolved in methanol and quantitatively diluted. After the internal standard was added, the sample was quantitatively diluted with methanol, and then entered into a high-performance liquid chromatography for chromatographic separation. The ultraviolet absorption detector was used to detect the peak area of hydrocortisone butyrate at a wavelength of 240 nm. And calculate its content.

Reagent:

Acetonitrile

Glacial acetic acid

3. Methanol

4. Testosterone

equipment:

Instrument

1.1 HPLC

1.2 Column

Octadecylsilane-bonded silica gel is used as a filler, and the theoretical plate number should not be lower than 1500 based on the calculation of hydrocortisone butyrate peak.

1.3 UV absorption detector

Chromatographic conditions

2.1 Mobile phase: water acetonitrile glacial acetic acid = 55 45 0.5

2.2 Detection wavelength: 240nm

2.3 Column temperature: room temperature

Sample preparation:

Preparation of internal standard solution

Accurately weigh the appropriate amount of methyltestosterone, add methanol to make a solution containing 0.18mg per 1mL, which is the internal standard solution.

2. Preparation of reference solution

Accurately weigh the appropriate amount of hydrocortisone butyrate reference solution, add methanol to dissolve and quantitatively dilute to a solution containing about 0.26mg per 1mL, accurately measure 5mL each of this solution and the internal standard solution, place in a 50mL volumetric flask, add methanol Dilute to the mark and shake well to obtain the reference solution.

Note: "Precision weighing" means that the weighed weight should be accurate to one thousandth of the weighed weight. "Precision measurement" means that the accuracy of measuring the volume should meet the accuracy requirements of the volume pipette in national standards.

Steps:

20 mL of each of the reference solution and the test solution were accurately pipetted, injected into a high-performance liquid chromatograph, and the peak area of hydrocortisone butyrate (C25H36O6) was measured with a UV absorption detector at a wavelength of 240 nm to calculate the content.

references:

Pharmacopoeia of the People's Republic of China, compiled by the National Pharmacopoeia Committee, Chemical Industry Press, 2005 Edition, Part Two, p.21.