Diazoxide Tablets
Action and use
Vasodilator; treatment of hypertension.
Definition
Diazoxide Tablets contain Diazoxide.
Content of diazoxide, C8H7ClN2O2S
92.5 to 107.5% of the stated amount.
Identification
Shake a quantity of the powdered tablets containing 0.2 g of Diazoxide with 50 mL of absolute ethanol, filter and evaporate the filtrate to dryness at a pressure of 2 kPa. The residue complies with the following tests.
20 volumes of acetone, 30 volumes of ether, and 50 volumes of toluene.
The principal spot in the chromatogram obtained with solution (1) corresponds in colour and intensity to that in the chromatogram obtained with solution (2).
TEST
Related substances
Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.
7 volumes of 18m ammonia, 25 volumes of methanol and 68 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) (0.5%).
Assay
Weigh and powder 20 tablets. To a quantity of the powder containing 50 mg of Diazoxide add 70 mL of methanol, shake for 1 hour, add sufficient methanol to produce 100 mL, mix and filter. Dilute 5 mL of the filtrate to 250 mL with 0.1m sodium hydroxide and measure the absorbance of the resulting solution at the maximum at 280 nm, Appendix II B. Calculate the content of C8H7ClN2O2S taking 585 as the value of A(1%, 1 cm) at the maximum at 280 nm.