Prednisolone Tablets
Action and use
Glucocorticoid.
Definition
Prednisolone Tablets contain Prednisolone.
Content of prednisolone, C21H28O5
90.0 to 110.0% of the stated amount.
Identification
Extract a quantity of the powdered tablets with acetone, filter and evaporate the filtrate to dryness. The residue complies with the following tests.
Tests
Dissolution
Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1.
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
The test is not valid unless, in the chromatogram obtained with solution (1), the column efficiency, determined using the peak due to prednisolone, is greater than 15,000 theoretical plates per metre.
Calculate the total content of C21H28O5 in the medium from the chromatograms obtained and using the declared content of C21H28O5 in prednisolone BPCRS.
Related substances
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
In the chromatogram obtained with solution (3), the retention times are about 14 minutes and 15.5 minutes for prednisolone and hydrocortisone respectively.
Mix 220 volumes of tetrahydrofuran with 700 volumes of water, allow to equilibrate, dilute to 1000 volumes with water and mix.
The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to prednisolone and hydrocortisone is at least 2.2. If necessary, adjust the concentration of tetrahydrofuran in the mobile phase.
In the chromatogram obtained with solution (1):
the area of any secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (1%);
the sum of the areas of any secondary peaks is not greater than three times the area of the principal peak in the chromatogram obtained with solution (2) (3%).
Disregard any peak with an area less than 0.05 times the area of the principal peak in the chromatogram obtained with solution (2) (0.05%) and any peak with a retention time of 3 minutes or less.
Uniformity of content
Tablets containing less than 2 mg and/or less than 2% w/w of Prednisolone comply with the requirements stated under Tablets using the following method of analysis. Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
42 volumes of water and 58 volumes of methanol.
The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to prednisolone and dexamethasone is greater than 2.5.
Calculate the content of C21H28O5 in each tablet using the declared content of C21H28O5 in prednisolone BPCRS.
Assay
Weigh and powder 20 tablets. Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
The assay is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to prednisolone and dexamethasone is greater than 2.5.
Calculate the content of C21H28O5 in the tablets using the declared content of C21H28O5 in prednisolone BPCRS.
Storage
Prednisolone Tablets should be protected from light.