Chloroquine Sulfate Tablets
Action and use
Antiprotozoal (malaria).
Definition
Chloroquine Sulfate Tablets contain Chloroquine Sulfate. They are coated.
Content of chloroquine sulfate, C18H26ClN3,H2SO4,H2O
92.5 to 107.5% 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 chloroquine sulfate, C18H26ClN3,H2SO4,H2O, in the medium taking 450 as the value of A(1%, 1 cm) at the maximum at 344 nm.
Related substances
Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.
10 volumes of diethylamine, 40 volumes of cyclohexane and 50 volumes of chloroform.
Any secondary spot in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (2) and not more than one such spot is more intense than the spot in the chromatogram obtained with solution (3).
Assay
Weigh and powder 20 tablets. Dissolve a quantity of the powder containing 0.5 g of Chloroquine Sulfate in 20 mL of 1m sodium hydroxide and extract with four 25-mL quantities of chloroform. Combine the chloroform extracts and evaporate to a volume of about 10 mL. Add 40 mL of anhydrous acetic acid and carry out Method I for non-aqueous titration, Appendix VIII A, determining the end point potentiometrically. Each mL of 0.1m perchloric acid VS is equivalent to 20.90 mg of C18H26ClN3,H2SO4.
200 mg of Chloroquine Sulfate is approximately equivalent to 146 mg of chloroquine.