Methylprednisolone Tablets
Action and use
Glucocorticoid.
Definition
Methylprednisolone Tablets contain Methylprednisolone.
Content of methylprednisolone, C22H30O5
90.0 to 110.0% of the stated amount.
Identification
Extract a quantity of the powdered tablets containing 50 mg with 100 mL of chloroform, filter and evaporate the filtrate to dryness. The residue complies with the following tests.
The test is not valid unless the chromatogram obtained with solution (3) shows two clearly separated spots.
The principal spot in the chromatogram obtained with solution (1) is similar in position, colour in daylight, fluorescence in ultraviolet light at 365 nm and size to that in the chromatogram obtained with solution (2).
Tests
Dissolution
Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1.
After 45 minutes withdraw a sample of the medium and measure the absorbance of the filtered sample, suitably diluted with the dissolution medium if necessary, at the maximum at 256 nm, Appendix II B using water in the reference cell.
Calculate the total content of methylprednisolone, C22H30O5, in the medium taking 400 as the value of A (1%, 1 cm) at the maximum at 256 nm.
Related substances
Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.
1.2 volumes of water, 8 volumes of methanol, 15 volumes of ether and 77 volumes of dichloromethane.
The test is not valid unless the chromatogram obtained with solution (4) shows two principal spots that are close together but separated.
Any secondary spot in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (2) (2%) and not more than one such spot is more intense than the spot in the chromatogram obtained with solution (3) (0.5%).
Assay
Weigh and powder 20 tablets. Suspend a quantity of the powder containing 10 mg of Methylprednisolone in 10 mL of water and extract with successive quantities of 100, 50, 50 and 40 mL of chloroform. Wash each extract with the same 10 mL quantity of water, filter and dilute the combined filtrates to 250 mL with chloroform. Evaporate 25 mL just to dryness, dissolve the residue in sufficient aldehyde-free ethanol (96%) to produce a solution containing between 390 and 410 µg of Methylprednisolone in 10 mL and complete the tetrazolium assay of steroids, Appendix VIII J, beginning at the words ‘Transfer 10 mL…’.
Dissolve a quantity of methylprednisolone BPCRS in sufficient aldehyde-free ethanol (96%) to produce a solution containing between 390 and 410 µg in 10 mL and complete the tetrazolium assay beginning at the words ‘Transfer 10 mL…’. From the absorbances so obtained, and using the declared content of C22H30O5 in methylprednisolone BPCRS, calculate the content of C22H30O5 in the tablets.
Storage
Methylprednisolone Tablets should be stored protected from light.