» Oxazepam Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C15H11ClN2O2.
Packaging and storage Preserve in well-closed containers.
Identification The solution prepared for measurement of absorbance in the Assay exhibits a maximum at 229 ± 2 nm.
Medium: 0.1 N hydrochloric acid; 1000 mL.
Apparatus 2: 50 rpm.
Time: 60 minutes.
Chromatographic system The liquid chromatograph is fitted with a 232-nm detector and a 4-mm × 30-cm column that contains packing L7. The mobile phase is a degassed mixture of methanol, water, and glacial acetic acid (60:40:1), and the flow rate is about 2 mL per minute. In a suitable system, the relative standard deviation observed following replicate injections is not more than 3.0%.
Procedure Inject an accurately measured volume (about 10 µL) of a filtered portion of the solution under test into the chromatograph by means of a microsyringe or a sampling valve, record the chromatogram, and measure the response for the major peak. Calculate the quantity of C15H11ClN2O2 dissolved in comparison with a similarly chromatographed Standard solution having a known concentration of USP Oxazepam RS in 0.1 N hydrochloric acid. [noteA volume of alcohol not exceeding 10% of the final total volume of the Standard solution may be used to dissolve the Reference Standard.]
Tolerances Not less than 80% (Q) of the labeled amount of C15H11ClN2O2 is dissolved in 60 minutes.
Uniformity of dosage units 905: meet the requirements.
Assay Weigh and finely powder not less than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 50 mg of oxazepam, to a medium-porosity, sintered-glass funnel that is fitted into a small suction flask, and proceed as directed in the Assay under Oxazepam Capsules, beginning with Add 25 mL of alcohol. Calculate the quantity, in mg, of C15H11ClN2O2 in the portion of Tablets taken by the formula:
12.5C(AU / AS)in which C is the concentration, in µg per mL, of USP Oxazepam RS in the Standard solution, and AU and AS are the absorbances of the solution from the Tablets and the Standard solution, respectively.
Auxiliary Information Please check for your question in the FAQs before contacting USP.Chromatographic Column
USP32NF27 Page 3155
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.