Diazepam Tablets
Action and use
Benzodiazepine.
Definition
Diazepam Tablets contain Diazepam.
Content of diazepam, C16H13ClN2O
92.5 to 107.5% of the stated amount.
Identification
10 volumes of methanol and 100 volumes of chloroform.
The principal spot in the chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (2).
Tests
Related substances and decomposition products
Carry out the procedure in subdued light. Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions in ethanol (96%).
Equal volumes of ethyl acetate and hexane.
Any secondary spot in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (2).
Dissolution
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 diazepam, C16H13ClN2O, in the medium taking 488 as the value of A(1%, 1 cm) at the maximum at 286 nm.
Uniformity of content
Tablets containing less than 2 mg and/or less than 2% w/w of Diazepam comply with the requirement stated under Tablets using the following method of analysis. To one tablet add 1 mL of water, allow the tablet to disintegrate and stand for 15 minutes. Add 80 mL of a 0.5% w/v solution of sulfuric acid in methanol, shake for 15 minutes, add sufficient of the methanolic sulfuric acid to produce 100 mL and filter. Measure the absorbance of the filtrate at the maximum at 284 nm, Appendix II B. Calculate the content of C16H13ClN2O taking 450 as the value of A(1%, 1 cm) at the maximum at 284 nm.
Assay
Weigh and powder 20 tablets. To a quantity of the powder containing 10 mg of Diazepam add 5 mL of water, mix and allow to stand for 15 minutes. Add 70 mL of a 0.5% w/v solution of sulfuric acid in methanol, shake for 15 minutes, add sufficient of the methanolic sulfuric acid to produce 100 mL and filter. Dilute 10 mL of the filtrate to 50 mL with the same solvent and measure the absorbance of the resulting solution at the maximum at 284 nm, Appendix II B. Calculate the content of C16H13ClN2O taking 450 as the value of A(1%, 1 cm) at the maximum at 284 nm.
Storage
Diazepam Tablets should be protected from light.