Fluvoxamine Tablets
Action and use
Selective serotonin reuptake inhibitor; antidepressant.
Definition
Fluvoxamine Tablets contain Fluvoxamine Maleate.
Content of fluvoxamine maleate, C15H21F3N2O2,C4H4O4
92.5 to 105.0% of the stated amount.
Identification
Tests
Dissolution
Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1.
After 20 minutes withdraw a 10-mL sample of the medium and centrifuge. Measure the absorbance of the clear supernatant liquid, suitably diluted with water if necessary, at the maximum at 244 nm, Appendix II B using water in the reference cell.
Calculate the total content of fluvoxamine maleate, C15H21F3N2O2,C4H4O4, in the medium taking 270 as the value of A(1%, 1 cm) at the maximum at 244 nm.
Related substances
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
40 volumes of a solution containing 1.25% w/v of diammonium hydrogen orthophosphate and 0.275% w/v of sodium heptanesulfonate monohydrate and 60 volumes of methanol, adjusting the pH of the mixture to 3.5 with orthophosphoric acid.
When the chromatograms are recorded under the prescribed conditions, the relative retention times with reference to fluvoxamine (retention time about 8 minutes) are: maleic acid, about 0.2; impurity C, about 0.6; impurity F, about 0.7; impurity B, about 0.8; impurity D, about 1.6 and impurity A, about 2.0.
The test is not valid unless, the chromatogram obtained with solution (3):
closely resembles the reference chromatogram supplied with fluvoxamine maleate impurity standard BPCRS;
the resolution between the peaks corresponding to fluvoxamine and impurity B is at least 1.5.
Identify the impurities from the chromatogram obtained with solution (3) and from the reference chromatogram supplied with the reference material.
In the chromatogram obtained with solution (1):
the area of any peak corresponding to impurity C is not greater than 3 times the area of the principal peak in the chromatogram obtained with solution (2) (3%);
the area of any peak corresponding to impurity B is not greater than half the area of the principal peak in the chromatogram obtained with solution (2) (0.5%);
the area of any peak corresponding to impurity D is not greater than the area of the principal peak in the chromatogram obtained with solution (4) (0.8%);
the area of any other secondary peak is not greater than 0.2 times the area of the principal peak in the chromatogram obtained with solution (2) (0.2%);
the sum of the areas of all the secondary peaks, other than any peaks corresponding to impurity C and impurity D, is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (1.0%).
Disregard the peak corresponding to maleic acid and any peak with an area less than the area of the principal peak in the chromatogram obtained with solution (5) (0.1%).
Assay
Weigh and powder 20 tablets. Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
The chromatographic conditions described under Related substances may be used.
Calculate the content of C15H21F3N2O2,C4H4O4 in the tablets using the declared content of C15H21F3N2O2,C4H4O4 in fluvoxamine maleate BPCRS.
Storage
Fluvoxamine Tablets should be protected from light.
IMPURITIES
The impurities limited by the requirements of this monograph include impurities A, B, C, D, E and F listed under Fluvoxamine Maleate.