Naproxen Sodium Tablets
» Naproxen Sodium Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of naproxen sodium (C14H13NaO3).
Packaging and storage Preserve in well-closed containers.
A: Transfer a quantity of finely powdered Tablets, equivalent to about 250 mg of naproxen sodium, to a centrifuge tube, and add 12 mL of water and 1 mL of hydrochloric acid: a dense white precipitate is formed. Centrifuge the mixture: the clear, supernatant responds to the identification test for Sodium 191.
Medium: 0.1 M phosphate buffer (pH 7.4), prepared by dissolving 2.62 g of monobasic sodium phosphate and 11.50 g of anhydrous dibasic sodium phosphate in water to make 1000 mL; 900 mL.
Apparatus 2: 50 rpm.
Time: 45 minutes.
Standard preparation Dissolve an accurately weighed portion of USP Naproxen Sodium RS in Medium to obtain a solution having a known concentration of about 50 µg per mL.
Procedure Dilute a filtered portion of the solution under test quantitatively with Medium as necessary to obtain a solution having a concentration of about 50 µg per mL of C14H13NaO3. Determine the amount of C14H13NaO3 dissolved from UV absorbances at the wavelength of maximum absorbance at about 332 nm of this solution in comparison with the Standard preparation.
Tolerances Not less than 80% (Q) of the labeled amount of C14H13NaO3 is dissolved in 45 minutes.
Uniformity of dosage units 905: meet the requirements.
Mobile phase , Solvent mixture, Internal standard solution, and Chromatographic systemPrepare as directed in the Assay under Naproxen Tablets.
Standard preparation Dissolve an accurately weighed quantity of USP Naproxen Sodium RS in Solvent mixture to obtain a solution having a known concentration of about 2.75 mg per mL. Transfer 1.0 mL of the resulting solution and 2.0 mL of Internal standard solution to a 100-mL volumetric flask, dilute with Mobile phase to volume, and mix. This solution contains about 27.5 µg of USP Naproxen Sodium RS per mL.
Assay preparation Weigh and finely powder not less than 20 Tablets. Transfer an accurately weighed quantity of the powder, equivalent to about 275 mg of naproxen sodium, to a 100-mL volumetric flask. Add 10 mL of water, and shake until the material is completely dispersed. Dilute with acetonitrile to volume, and mix. Allow any insoluble matter to settle, then transfer 1.0 mL of the clear supernatant to a 100-mL volumetric flask, add 2.0 mL of Internal standard solution, dilute with Mobile phase to volume, and mix.
Procedure Proceed as directed for Procedure in the Assay under Naproxen Tablets. Calculate the quantity, in mg, of C14H13NaO3 in the portion of Tablets taken by the formula:
10C(RU / RS)in which C is the concentration, in µg per mL, of USP Naproxen Sodium RS in the Standard preparation, and RU and RS are the ratios of the response of the naproxen peak to the response of the internal standard peak obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information Please check for your question in the FAQs before contacting USP.Chromatographic Column
USP32NF27 Page 3038
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.