Chlorpromazine Tablets
Action and use
Dopamine receptor antagonist; neuroleptic.
Definition
Chlorpromazine Tablets contain Chlorpromazine Hydrochloride. They are coated.
Content of chlorpromazine hydrochloride, C17H19ClN2S,HCl
92.5 to 107.5% of the stated amount.
Identification
Tests
Related substances
Comply with the test for related substances in phenothiazines, Appendix III A, using mobile phase A and the following freshly prepared solutions. For solution (1) extract a quantity of the powdered tablets containing 0.1 g of Chlorpromazine Hydrochloride with 10 mL of a mixture of 95 volumes of methanol and 5 volumes of diethylamine and filter. For solution (2) dilute 1 volume of solution (1) to 200 volumes with the same solvent mixture.
Dissolution
Carry out the procedure protected from light. 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 C17H19ClN2S,HCl, in the medium taking 914 as the value of A(1%, 1 cm) at the maximum at 254 nm.
Assay
Carry out the following procedure protected from light. Powder 10 tablets without loss, triturate the powder with 10 mL of absolute ethanol, add about 300 mL of 0.1m hydrochloric acid and shake for 15 minutes. Add sufficient 0.1m hydrochloric acid to produce 500 mL, filter, dilute a volume of the filtrate containing 5 mg of Chlorpromazine Hydrochloride to 100 mL with 0.1m hydrochloric acid and further dilute 10 mL to 100 mL with the same solvent. Measure the absorbance of the resulting solution at the maximum at 254 nm, Appendix II B. Calculate the content of C17H19ClN2S,HCl taking 915 as the value of A(1%, 1 cm) at the maximum at 254 nm.