Diclofenac Potassium Tablets
» Diclofenac Potassium Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of diclofenac potassium (C14H10Cl2KNO2).
Packaging and storage—
Preserve in tight, light-resistant containers, and store at controlled room temperature.
Identification—
A:
The retention time of the diclofenac peak in the chromatogram of the Assay preparation corresponds to that of the Standard preparation, as obtained in the Assay.
Change to read:
Dissolution ![]() ![]()
Medium:
simulated intestinal fluid (without enzyme); 900 mL.
Apparatus 2:
50 rpm.
Time:
60 minutes.
Procedure—
Determine the amount of C14H10Cl2KNO2 dissolved by employing UV absorption at the wavelength of maximum absorbance at about 276 nm on portions of the solution under test passed through a 0.45-µm filter, suitably diluted with Medium, if necessary, in comparison with a Standard solution having a known concentration of USP Diclofenac Potassium RS in the same Medium. Calculate the percentage of diclofenac potassium (C14H10Cl2KNO2) dissolved by the formula:
in which AU and AS are the absorbances obtained from the solution under test and the Standard solution, respectively; CS is the concentration, in mg per mL, of the Standard solution; 900 is the volume, in mL, of Medium; 100 is the conversion factor to percentage; and LC is the Tablet label claim, in mg, of diclofenac potassium.
Tolerances—
Not less than
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Uniformity of dosage units:
meets the requirements.
Delete the following:
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Delete the following:
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Standard—
Accurately transfer about 50.00 mg of potassium chloride into a fused quartz crucible.
Sample—
Transfer not fewer than five diclofenac potassium 50-mg Tablets, accurately weighed, into a fused quartz crucible.
Blank—
Prepare a dilution of 10% cesium chloride (1 in 50).
Test solutions—
Place crucibles containing the Standard, Sample, and Blank in a muffle furnace at 550
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Procedure—
Concomitantly determine the absorbances of the Test solutions and Blank at the potassium emission line at 766.5 nm with a suitable atomic absorption spectrophotometer (see Spectrophotometry and Light-Scattering
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Change to read:
Related compounds—
pH 2.5 Phosphate buffer, Mobile phase, Diluent, Resolution solution, and Chromatographic system—
Prepare as directed in the Assay.
Standard solution—
Dissolve an accurately weighed quantity of USP Diclofenac Related Compound A RS in Diluent, and dilute quantitatively, and stepwise if necessary, to obtain a solution having a known concentration of about
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Test solution—
Use the Assay preparation.
Procedure—
Separately inject equal volumes (about 30 µL) of the Standard solution and the Test solution into the chromatograph, record the chromatograms, and measure the peak responses. Calculate the percentage of diclofenac related compound A
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Change to read:
Assay—
pH 2.5 Phosphate buffer—
Mix equal volumes of 0.01 M phosphoric acid and 0.01 M monobasic sodium phosphate. If necessary, adjust with additional portions of the appropriate components to a pH of 2.5 ± 0.2.
Mobile phase—
Prepare a filtered and degassed mixture of methanol and pH 2.5 Phosphate buffer (70:30). Make adjustments if necessary (see System Suitability under Chromatography
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Diluent—
Prepare a mixture of methanol and water (70:30).
Standard preparation—
Dissolve an accurately weighed quantity of USP Diclofenac Potassium RS in Diluent, and dilute quantitatively, and stepwise if necessary, to obtain a solution having a known concentration of about
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Assay preparation—
Weigh and finely powder not fewer than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 50 mg of diclofenac potassium, to a 100-mL volumetric flask. Add about 70 mL of Diluent, stir for 60 minutes, dilute with Diluent to volume, mix, and centrifuge.
Resolution solution—
Prepare a solution in Diluent containing 40 µg per mL of diethyl phthalate, 0.5 mg per mL of USP Diclofenac Potassium RS, and 37.5 µg per mL of USP Diclofenac Potassium Related Compound A RS.
Chromatographic system (see Chromatography
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Procedure—
Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the
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Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
Chromatographic Column—
USP32–NF27 Page 2122
Pharmacopeial Forum: Volume No. 34(2) Page 257
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
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