Naproxen Delayed-Release Tablets
» Naproxen Delayed-Release Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of naproxen (C14H14O3).
Packaging and storage— Preserve in well-closed containers, and store at controlled room temperature.
USP Reference standards 11
USP Naproxen RS Click to View Structure
Identification—
A: Ultraviolet Absorption 197U
Test solution— Use the solution under test as obtained in the Buffer stage of the Dissolution test.
Standard solution— Use the Standard solution prepared as directed in the Buffer stage of the Dissolution test.
B: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Dissolution, Delayed-Release Dosage Forms, Method B 711
acid stage—
Acid stage medium: 0.1 N hydrochloric acid; 1000 mL.
Apparatus 2: 50 rpm.
Time: 2 hours.
Procedure— Determine the amount of C14H14O3 dissolved by employing UV absorption at the wavelength of maximum absorbance at about 332 nm on filtered portions of the solution under test, suitably diluted with Acid stage medium, if necessary, in comparison with a Standard solution having a known concentration of USP Naproxen RS in the same Acid stage medium.
Tolerances— Not more than 10% (Q) of the labeled amount of C14H14O3 is dissolved in 2 hours.
buffer stage
Buffer stage medium: 0.2 M phosphate buffer, pH 6.8; 1000 mL.
Apparatus 2: 50 rpm.
Time: 45 minutes.
Procedure— Determine the amount of C14H14O3 dissolved by employing UV absorption at the wavelength of maximum absorbance at about 332 nm on filtered portions of the solution under test, suitably diluted with Buffer stage medium, if necessary, in comparison with a Standard solution having a known concentration of USP Naproxen RS in the same Buffer stage medium.
Tolerances— Not less than 80% (Q) of the labeled amount of C14H14O3 is dissolved in 45 minutes.
Uniformity of dosage units 905: meet the requirements.
procedure for content uniformity
Mobile phase, Diluent A, Diluent B, and Chromatographic system— Proceed as directed in the Assay.
Standard solution— Transfer about 12.5 mg of USP Naproxen RS, accurately weighed, to a 50-mL volumetric flask, dilute with Diluent A to volume, and mix well. Transfer 10 mL of this solution to a 25-mL volumetric flask, dilute with Diluent B to volume, and mix.
Test solution— Transfer 1 Tablet to a 200-mL volumetric flask, and add about 140 mL of Diluent B. Shake by mechanical means for 15 minutes, sonicate for 15 minutes, dilute with Diluent B to volume, and mix. Pass a portion of this solution through a filter having a porosity of 0.45-µm, pipet 2.0 mL of the filtrate for a 500-mg tablet and 2.5 mL for a 375-mg tablet into a 50-mL volumetric flask, dilute with Mobile phase to volume, and mix.
Assay—
Mobile phase— Prepare a filtered and degassed mixture of 1% acetic acid solution and acetonitrile (11:9).
Diluent A— Use acetonitrile and water (9:1).
Diluent B— Use acetonitrile and water (1:1).
Standard stock preparation— Transfer about 12.5 mg of USP Naproxen RS, accurately weighed, to a 25-mL volumetric flask. Dissolve in and dilute with Diluent A to volume, and mix.
Standard preparation— Accurately transfer 10.0 mL of the Standard stock preparation into a 50-mL volumetric flask, and dilute with Mobile phase to volume, and mix.
Assay preparation— Weigh and powder 20 Tablets. Accurately weigh an amount of the powder, equivalent to about 250 mg of naproxen, into a 100-mL volumetric flask, and add about 70 mL of Diluent B. Shake by mechanical means for 15 minutes, sonicate for 15 minutes, dilute with Diluent B to volume, and mix. Pass this solution through a filter having a porosity of 0.45-µm, transfer 2.0 mL of the filtrate into a 50-mL volumetric flask, dilute with Mobile phase to volume, and mix.
Chromatographic system (see Chromatography 621)— The liquid chromatograph is equipped with a 254-nm detector and a 4.6-mm × 25-cm column that contains 5-µm packing L1. The flow rate is about 1.0 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the tailing factor of the naproxen peak is not more than 1.5, and the relative standard deviation for replicate injections of the Standard preparation is not more than 2.0%.
Procedure— Separately inject equal volumes (about 50 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the naproxen peak. Calculate the quantity, in mg, of naproxen (C14H14O3) in the portion of Tablets taken by the formula:
2500C(rU / rS)
in which C is the concentration, in mg per mL, of USP Naproxen RS in the Standard preparation; and rU and rS are the peak responses 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 3996
Pharmacopeial Forum: Volume No. 33(6) Page 1192