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.
Change to read:
Identification
A:
Ultraviolet Absorption 197U
Test solution
Use the solution under test as obtained in the Buffer stage of the DissolutionUSP32 test.
Standard solution
Use the Standard solution prepared as directed in the Buffer stage of the DissolutionUSP32 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.
Change to read:
Dissolution, Delayed-Release Dosage Forms, Method B 711USP32
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.
Chromatographic Column
USP32NF27 Page 3036
Pharmacopeial Forum: Volume No. 33(6) Page 1192
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
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