Prochlorperazine Buccal Tablets
Action and use
Dopamine receptor antagonist; neuroleptic.
Definition
Prochlorperazine Buccal Tablets contain Prochlorperazine Maleate in a suitable basis.
Content of prochlorperazine maleate, C20H24ClN3S,2C4H4O4
92.5 to 107.5% of the stated amount.
Identification
To a quantity of the powdered tablets containing 24 mg of Prochlorperazine Maleate add 10 mL of water and 1 mL of 1m sodium hydroxide, shake, extract with 25 mL of dichloromethane and evaporate to dryness. The infrared absorption spectrum of a thin film of the residue, Appendix II A, is concordant with the reference spectrum of prochlorperazine (RS 390).
Related substances
Carry out the method for thin-layer chromatography, Appendix III A, protected from light using a silica gel F254 precoated plate (Merck silica gel 60 F254 plates are suitable) and a mixture of 10 volumes of acetone, 10 volumes of diethylamine, and 80 volumes of cyclohexane as the mobile phase. Apply separately to the plate 10 µL of each of the following solutions. For solution (1) extract a quantity of the powdered tablets containing 60 mg of Prochlorperazine Maleate with 5 mL of 0.18m methanolic ammonia, shake for 15 minutes, centrifuge and use the supernatant liquid. Solution (2) contains 0.006% w/v of prochlorperazine maleate BPCRS in 0.18m methanolic ammonia. After removal of the plate, allow it to dry in air and examine under ultraviolet light (254 nm). Any secondary spot in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (2) (0.5%). Disregard any spot remaining on the line of application.
Assay
Weigh and finely powder 20 tablets. To a quantity of the powdered tablets containing 10 mg of Prochlorperazine Maleate add 50 mL of 1m methanesulfonic acid, shake for 5 minutes and disperse with the aid of ultrasound for 2 minutes. Add sufficient 1m methanesulfonic acid to produce 100 mL, mix, centrifuge the mixture and dilute 10 mL of the supernatant liquid to 100 mL with water. Measure the absorbance of the resulting solution at 254 nm, Appendix II B, using 0.1m methanesulfonic acid in the reference cell. Measure the absorbance of a solution prepared by diluting 1 volume of a 0.01% w/v solution of prochlorperazine maleate BPCRS in 1m methanesulfonic acid to 10 volumes with water using 0.1m methanesulfonic acid in the reference cell. Calculate the content of C20H24ClN3S,2C4H4O4 from the absorbances obtained and from the declared content of C20H24ClN3S,2C4H4O4 in prochlorperazine maleate BPCRS.
Storage
Prochlorperazine Buccal Tablets should be protected from light.