Oxazepam Tablets
Action and use
Benzodiazepine.
Definition
Oxazepam Tablets contain Oxazepam.
Content of oxazepam, C15H11ClN2O2
90.0 to 110.0% of the stated amount.
Identification
Tests
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 oxazepam, C15H11ClN2O2, in the medium taking 1080 as the value of A(1%, 1 cm) at the maximum at 236 nm.
Related substances
Carry out the following procedure protected from light. Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.
10 volumes of methanol and 100 volumes of dichloromethane.
The test is not valid unless the chromatogram obtained with solution (4) shows two clearly separated spots.
In the chromatogram obtained with solution (1):
any secondary spot is not more intense than the spot in the chromatogram obtained with solution (2) (1%),
not more than one such spot is more intense than the spot in the chromatogram obtained with solution (3) (0.2%).
Assay
Weigh and powder 20 tablets. To a quantity of the powder containing 25 mg of Oxazepam add 150 mL of ethanol (96%) and shake for 30 minutes. Add sufficient ethanol (96%) to produce 250 mL, centrifuge, dilute 5 mL of the supernatant liquid to 100 mL with the same solvent and measure the absorbance of the resulting solution at the maximum at 230 nm, Appendix II B. Calculate the content of C15H11ClN2O2 taking 1250 as the value of A(1%, 1 cm) at the maximum at 230 nm.
Storage
Oxazepam Tablets should be protected from light.