Sulpiride Tablets
Action and use
Dopamine receptor antagonist; neuroleptic.
Definition
Sulpiride Tablets contain Sulpiride.
Content of sulpiride, C15H23N3O4S
95.0 to 105.0% of the stated amount.
Identification
To a quantity of the powdered tablets containing 0.2 g of Sulpiride add 20 mL of methanol, shake for 5 minutes, filter and evaporate the filtrate to dryness. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of sulpiride (RS 391).
Related substances
2 volumes of 13.5m ammonia, 10 volumes of 1,4-dioxan, 14 volumes of methanol and 90 volumes of dichloromethane.
Any spot in the chromatogram obtained with solution (1) corresponding to the principal spot in the chromatogram obtained with solution (2) is not more intense than the spot in the chromatogram obtained with solution (3) (0.1%).
10 volumes of acetonitrile, 10 volumes of methanol and 80 volumes of a solution containing 6.8% w/v of potassium dihydrogen orthophosphate and 0.1% w/v of sodium octanesulfonate, adjusted to pH 3.3 using orthophosphoric acid.
The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the two principal peaks is at least 2.5.
In the chromatogram obtained with solution (1):
the sum of the areas of any secondary peaks is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.3%).
Assay
Weigh and powder 20 tablets. Mix a quantity of the powder containing 0.1 g of Sulpiride with about 50 mL of 0.1m sodium hydroxide for 5 minutes with the aid of ultrasound, add sufficient 0.1m sodium hydroxide to produce 100 mL and filter, discarding the first 10 mL of filtrate. Dilute 5 mL of the filtrate to 100 mL with 0.1m sodium hydroxide and measure the absorbance of the solution at the maximum at 291 nm, Appendix II B, using 0.1m sodium hydroxide in the reference cell. Calculate the content of C15H23N3O4S in the tablets from the absorbance of a 0.005% w/v solution of sulpiride BPCRS in 0.1m sodium hydroxide using the declared content of C15H23N3O4S in sulpiride BPCRS.
IMPURITIES
The impurities limited by the requirements of this monograph include those listed under Sulpiride.