Fluphenazine Tablets
Action and use
Dopamine receptor antagonist; neuroleptic.
Definition
Fluphenazine Tablets contain Fluphenazine Hydrochloride. They are coated.
Content of fluphenazine hydrochloride, C22H26F3N3OS,2HCl
90.0 to 110.0% of the stated amount.
Identification
2 volumes of diethylamine and 100 volumes of petroleum spirit (boiling range, 40° to 60°) saturated with 2-phenoxyethanol.
The principal spot in the chromatogram obtained with solution (1) corresponds in position, fluorescence and colour to that in the chromatogram obtained with solution (2).
Tests
Related substances
Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.
5 volumes of 13.5m ammonia, 30 volumes of cyclohexane and 80 volumes of acetone.
Any secondary spot in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (2) (1%) and not more than two such spots are more intense than the spot in the chromatogram obtained with solution (3) (0.5%). Disregard any spot remaining on the line of application.
Uniformity of content
Tablets containing less than 2 mg and/or less than 2% w/w of Fluphenazine Hydrochloride comply with the requirements stated under Tablets using the following method of analysis. Carry out the following procedure protected from light. Record second-derivative ultraviolet absorption spectra of the following solutions in the range 230 to 300 nm, Appendix II B. For solution (1) add 2 mL of 0.1m hydrochloric acid to one tablet and mix with the aid of ultrasound until the tablet is dispersed. Add 60 mL of a mixture of 1 volume of 1m hydrochloric acid and 99 volumes of ethanol (80%), shake for 20 minutes, dilute to 100 mL with the same solvent mixture, mix and filter. Solution (2) contains 0.001% w/v of fluphenazine hydrochloride BPCRS.
For each solution measure the amplitude from the peak at about 266 nm to the trough at about 258 nm. Calculate the content of C22H26F3N3OS,2HCl in each tablet using the declared content of C22H26F3N3OS,2HCl in fluphenazine hydrochloride BPCRS.
Assay
For tablets containing less than 2 mg and/or less than 2% w/w of Fluphenazine Hydrochloride
Use the average of the individual results determined in the test for Uniformity of content.
For tablets containing 2 mg or more and 2% w/w or more of Fluphenazine Hydrochloride
Carry out the following procedure protected from light. Record second-derivative ultraviolet absorption spectra of the following solutions in the range 230 to 300 nm, Appendix II B. For solution (1) add 20 mL of 0.1m hydrochloric acid to 10 tablets, mix with the aid of ultrasound until the tablets are dispersed, add 600 mL of a mixture of 1 volume of 1m hydrochloric acid and 99 volumes of ethanol (80%), shake for 20 minutes, dilute to 1000 mL with the same solvent mixture, mix and filter. Solution (2) contains 0.001% w/v of fluphenazine hydrochloride BPCRS.
For each solution measure the amplitude from the peak at about 266 nm to the trough at about 258 nm. Calculate the content of C22H26F3N3OS,2HCl in the tablets using the declared content of C22H26F3N3OS,2HCl in fluphenazine hydrochloride BPCRS.