A: The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that of the Standard preparation,as obtained in the Assay.

B: Accurately weigh an amount of Tablet mass,equivalent to 10mg of diazepam,place in a 50-mLcentrifuge tube,and add 2mLof acetone.Place the centrifuge tube in an ultrasonic bath for 5minutes,and centrifuge.Using 100µLof the supernatant as the test solution,100µLof a solution of USP Diazepam RSin acetone containing 5mg per mLas the Standard solution,and a solvent system consisting of equal volumes of ethyl acetate and n-heptane,proceed as directed in Identificationtest Bunder Diazepam.The specified result is observed.

Medium: 0.1Nhydrochloric acid;900mL.

Apparatus 1: 100rpm.

Time: 30minutes.

Procedure— Determine the amount of C16H13ClN2Odissolved by employing UVabsorption at a wavelength of about 242nm on filtered portions of the solution under test,suitably diluted with Dissolution Medium,if necessary,in comparison with a Standard solution having a known concentration of USP Diazepam RSin the same Medium.

Tolerances— Not less than 85%(Q)of the labeled amount of C16H13ClN2Ois dissolved in 30minutes.

Mobile phase,System suitability solution,Standard preparation,and Chromatographic system— Prepare as directed in the Assayunder Diazepam.

Assay preparation— Weigh and finely powder not less than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 10mg of diazepam,to a 100-mLvolumetric flask.Add about 50mLof methanol,sonicate for 5minutes,shake by mechanical means for 5minutes,dilute with methanol to volume,mix,and filter,discarding the first few mLof the filtrate.

Procedure— Proceed as directed for Procedurein the Assayunder Diazepam.Calculate the quantity,in mg,of diazepam (C16H13ClN2O)in the portion of Tablets taken by the formula: in which Cis the concentration,in mg per mL,of USP Diazepam RSin the Standard preparation,and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.