Ketorolac Tromethamine Tablets

» Ketorolac Tromethamine Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of ketorolac tromethamine (C15H13NO3·C4H11NO3).

Packaging and storage— Preserve in well-closed containers at controlled room temperature, protected from light and excessive humidity.

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USP Ketorolac Tromethamine RS

Identification— Prepare a mixture of the Standard preparation and the Assay preparation (1:1), and chromatograph the mixture as directed in the Assay. The chromatogram thus obtained exhibits two main peaks corresponding to ketorolac and the internal standard.

Dissolution

711

—

Medium: water; 600 mL.

Apparatus 2: 50 rpm.

Time: 45 minutes.

Procedure— Determine the amount of ketorolac tromethamine (C15H13NO3·C4H11NO3) dissolved from UV absorbance at about 322 nm 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 RS in the same Medium.

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

Uniformity of dosage units

905

: meet the requirements.

Procedure for content uniformity— Transfer 1 Tablet to a suitable volumetric flask that will provide a final concentration of about 0.1 mg 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 10 minutes to dissolve the ketorolac tromethamine. Cool to ambient temperature, dilute with methanol to volume, and mix. Centrifuge or allow to settle. Transfer 6.0 mL of the clear supernatant to a 50-mL volumetric flask, dilute with methanol to volume, and mix. Dissolve an accurately weighed quantity of USP Ketorolac Tromethamine RS quantitatively in methanol to obtain a Standard solution having a known concentration of about 12 µg per mL. Concomitantly determine the absorbances of both solutions at the wavelength of maximum absorbance at about 322 nm, using methanol as the blank. Calculate the quantity, in mg, of ketorolac tromethamine (C15H13NO3·C4H11NO3) in the Tablet taken by the formula:

(CV/120)(AU / AS)

in which C is the concentration, in µg per mL, of USP Ketorolac Tromethamine RS in the Standard solution; V is the volume, in mL, of the volumetric flask used in the initial step of tablet dissolution; and AU and AS are the absorbances of the test solution and the Standard solution, respectively.

Assay—

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

Assay preparation— Transfer 10 Tablets to a suitable volumetric flask that will provide a final concentration of about 0.2 mg 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 10 minutes to dissolve the ketorolac tromethamine. Cool to ambient temperature, dilute with methanol to volume, and mix. Centrifuge or allow to settle. Transfer 5.0 mL of the clear supernatant and 5.0 mL of the Internal standard solution to a 50-mL volumetric flask, dilute with Solvent mixture to volume, and mix. [note—Protect this solution from light. ]

Procedure— Proceed as directed for Procedure in the Assay under Ketorolac Tromethamine Injection. Calculate the quantity, in mg, of ketorolac tromethamine (C15H13NO3·C4H11NO3) in each Tablet taken by the formula:

(CV / 10)(RU / RS)

in which C is the concentration, in mg per mL, of USP Ketorolac Tromethamine RS in the Standard stock solution; V is the volume, in mL, of the volumetric flask used in the initial step of Tablet dissolution; and RU and RS are the ratios of the response of the ketorolac peak to the response of the naproxen peak obtained from the Assay preparation and the Standard preparation, respectively.

Auxiliary Information— Please check for your question in the FAQs before contacting USP.

Topic/Question	Contact	Expert Committee
Monograph	Clydewyn M. Anthony, Ph.D. Senior Scientific Liaison 1-301-816-8139	(SM22010) Monographs - Small Molecules 2
Reference Standards	RS Technical Services 1-301-816-8129 rstech@usp.org
711	Margareth R.C. Marques, Ph.D. Senior Scientific Liaison 1-301-816-8106	(GCDF2010) General Chapters - Dosage Forms

USP35–NF30 Page 3625