Medium: water;600mL.

Apparatus 2: 50rpm.

Time: 45minutes.

Procedure— Determine the amount of ketorolac tromethamine (C15H13NO3·C4H11NO3)dissolved from UVabsorbance at about 322nm of filtered portions of the solution under test,suitably diluted with Medium,in comparison with a Standard solution having a known concentration of USP Ketorolac Tromethamine RSin the same Medium.

Tolerances— Not less than 75%(Q)of the labeled amount of ketorolac tromethamine (C15H13NO3·C4H11NO3)is dissolved in 45minutes.

Procedure for content uniformity— Transfer 1Tablet to a suitable volumetric flask that will provide a final concentration of about 0.1mg of ketorolac tromethamine per mL.Add a quantity of water equivalent to about 10%of the volume of the flask,and sonicate until the Tablet is disintegrated.Add a quantity of methanol equivalent to 40%of the volume of the flask,and sonicate for about 10minutes to dissolve the ketorolac tromethamine.Cool to ambient temperature,dilute with methanol to volume,and mix.Centrifuge or allow to settle.Transfer 6.0mLof the clear supernatant to a 50-mLvolumetric flask,dilute with methanol to volume,and mix.Dissolve an accurately weighed quantity of USP Ketorolac Tromethamine RSquantitatively in methanol to obtain a Standard solution having a known concentration of about 12µg per mL.Concomitantly determine the absorbances of both solutions at the wavelength of maximum absorbance at about 322nm,using methanol as the blank.Calculate the quantity,in mg,of ketorolac tromethamine (C15H13NO3·C4H11NO3)in the Tablet taken by the formula: in which Cis the concentration,in µg per mL,of USP Ketorolac Tromethamine RSin the Standard solution,Vis the volume,in mL,of the volumetric flask used in the initial step of tablet dissolution,and AUand ASare the absorbances of the test solution and the Standard solution,respectively.

Mobile phase ,Solvent mixture,Internal standard solution,Standard stock solution,Standard preparation,and Chromatographic system—Proceed as directed in the Assayunder Ketorolac Tromethamine Injection.

Assay preparation— Transfer 10Tablets to a suitable volumetric flask that will provide a final concentration of about 0.2mg of ketorolac tromethamine per mL.Add a quantity of water equivalent to about 10%of the volume of the flask,and sonicate until the Tablets are disintegrated.Add a quantity of methanol equivalent to 40%of the volume of the flask,and sonicate for about 10minutes to dissolve the ketorolac tromethamine.Cool to ambient temperature,dilute with methanol to volume,and mix.Centrifuge or allow to settle.Transfer 5.0mLof the clear supernatant and 5.0mLof the Internal standard solutionto a 50-mLvolumetric flask,dilute with Solvent mixtureto volume,and mix.[NOTE—Protect this solution from light.]

Procedure— Proceed as directed for Procedurein the Assayunder Ketorolac Tromethamine Injection.Calculate the quantity,in mg,of ketorolac tromethamine (C15H13NO3·C4H11NO3)in each Tablet taken by the formula: in which Cis the concentration,in mg per mL,of USP Ketorolac Tromethamine RSin the Standard stock solution;Vis the volume,in mL,of the volumetric flask used in the initial step of Tablet dissolution;and RUand RSare the ratios of the response of the ketorolac peak to the response of the naproxen peak obtained from the Assay preparationand the Standard preparation,respectively.