Ibuprofen Tablets
Action and use
Cyclo-oxygenase inhibitor; analgesic; anti-inflammatory.
Definition
Ibuprofen Tablets contain Ibuprofen. They are coated.
Content of ibuprofen, C13H18O2
95.0 to 105.0% of the stated amount.
Identification
Test
Related substances
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
0.5 volume of orthophosphoric acid, 340 volumes of acetonitrile and 600 volumes of water diluted to 1000 volumes with water after equilibration.
In the chromatogram obtained with solution (3) measure the height (a) of the peak due to 2-(4-butylphenyl)-propionic acid and the height (b) of the lowest point of the curve separating this peak from that due to ibuprofen. The test is not valid unless a is greater than 1.5b. If necessary, adjust the concentration of acetonitrile in the mobile phase to obtain the required resolution.
In the chromatogram obtained with solution (1):
the area of any peak corresponding to ibuprofen impurity B is not greater than the area of the corresponding peak in the chromatogram obtained with solution (3) (0.3%);
the area of any other secondary peak is not greater than 0.3 times the area of the principal peak in the chromatogram obtained with solution (2) (0.3%);
the sum of the area of any secondary peaks, other than the peak due to impurity B, is not greater than 0.7 times the area of the principal peak in the chromatogram obtained with solution (2) (0.7%).
Disregard any peak the area of which is less than 0.1 times the area of the principal peak in the chromatogram obtained with solution (2) (0.1%).
Assay
Weigh and powder 20 tablets. Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
3 volumes of orthophosphoric acid, 247 volumes of water and 750 volumes of methanol.
Calculate the content of C13H18O2 using the declared content of C13H18O2 in ibuprofen BPCRS.
Impurities
The impurities limited by the requirements of this monograph include:
1. (2RS)-2-(4-butylphenyl)propanoic acid (Ibuprofen Impurity B).