Paroxetine Tablets
Action and use
Selective serotonin reuptake inhibitor; antidepressant.
Definition
Paroxetine Tablets contain Paroxetine Hydrochloride Hemihydrate or Paroxetine Hydrochloride. They are coated.
Production
The manufacturing process of Paroxetine Hydrochloride, used in the formulation of Paroxetine Tablets, is validated to show that the content of 4-(4′-fluorophenyl)-1-methyl-1,2,3,6-tetrahydropyridine is not more than 1 ppm.
Content of anhydrous paroxetine hydrochloride, C19H20FNO3,HCl
95.0 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.
Calculate the total content of paroxetine hydrochloride, C19H20FNO3,HCl, in the medium from the absorbances obtained and from the declared content of C19H20FNO3,HCl in paroxetine hydrochloride hemihydrate BPCRS.
Related substances
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
Mobile phase AEqual volumes of acetonitrile and phosphate buffer pH 6.0 prepared by dissolving 4.9 g of orthophosphoric acid in about 800 mL of water, adjusting the pH to 6.0 with 1m sodium hydroxide and diluting to 1000 mL with water.
Mobile phase BPhosphate buffer pH 6.0 prepared by dissolving 4.9 g of orthophosphoric acid in about 800 mL, adjusting the pH to 6.0 with 1m sodium hydroxide and diluting to 1000 mL with water.
The test is not valid unless the chromatogram obtained with solution (3) closely resembles the reference chromatogram supplied with paroxetine impurity standard BPCRS.
Identify any peak due to impurity I in the chromatogram obtained with solution (1), using the chromatogram obtained with solution (3), and multiply the area of this peak by a correction factor of 2.
In the chromatogram obtained with solution (1):
the area of any peak corresponding to impurity A is not greater than 1.5 times the area of the principal peak in the chromatogram obtained with solution (4) (0.3%);
the area of any peak corresponding to impurity I is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.2%);
the area of any other secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.2%);
the sum of the areas of any other secondary peaks is not greater than 2.5 times the area of the principal peak in the chromatogram obtained with solution (2) (0.5%);
Disregard any peak with with an area less than half 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.
Equal volumes of acetonitrile and phosphate buffer pH 6.0 prepared by dissolving 4.9 g of orthophosphoric acid in about 800 mL of water, adjusting the pH to 6.0 with 1m sodium hydroxide and diluting to 1000 mL with water.
The test is not valid unless, the chromatogram obtained with solution (3) closely resembles the chromatogram supplied with paroxetine impurity standard BPCRS.
Calculate the content of paroxetine hydrochloride, C19H20FNO3,HCl, in the tablets using the declared content of C19H20FNO3,HCl in paroxetine hydrochloride hemihydrate BPCRS.
Labelling
When the active ingredient is Paroxetine Hydrochloride Hemihydrate, the quantity is stated in terms of the equivalent amount of anhydrous paroxetine hydrochloride.
Storage
Paroxetine Tablets should be protected from light.
Impurities
The impurities limited by the requirements of this monograph include impurity A listed under Paroxetine Hydrochloride and Paroxetine Hydrochloride Hemihydrate, impurities B and I listed under Paroxetine Hydrochloride and the following: