Etodolac Extended-Release Tablets

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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Etodolac Extended-Release Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of etodolac (C₁₇H₂₁NO₃).

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

Labeling—When more than one Dissolution Test is given, the labeling states the Dissolution Test used only if Test 1 is not used.

Identification—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 (711)-

TEST 1-

Medium: 0.05 M phosphate buffer, pH 7.4; 1000 mL.

Apparatus 2: 75 rpm, with USP sinker.

Times: 3, 6, 10, and 16 hours.

Procedure-Determine the amount of C, H,, NO, dissolved by employing UV absorption at the wavelength of maximum absorbance at about 279 nm on filtered portions of the solution under test, suitably diluted with Medium, if necessary, in comparison with a Standard solution having a known concentration of USP Etodolac RS in the same Medium Use Medium as the blank.

Tolerances-The percentages of the labeled amount of (C₁₇H₂₁NO₃) dissolved at the times specified conform to Acceptance Table 2.

TEST 2-If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 2.

Medium: 0.05 M phosphate buffer, pH 7.5, 1000 mL

Apparatus 2: 100 rpm.

Times: 2, 4, 8, and 14 hours.

Procedure-Determine the amount of C₁₇H₂₁NO₃ dissolved by comparing the difference between the absorbances of the filtered portions of the solution under test determined at 278 nm and 245 nm with the difference between the absorbances of a Standard solution having a known concentration of USP Etodolac RS in the same Medium determined at the same wavelengths. Use Medium as the blank, and use a 0.05-cm silica cell.

Tolerances-The permentages of the labeled amount of C₁₇H₂₁NO₃  dissolved at the times specified conform to Accettance Table 2

test 3—If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 3.

Medium: 0.05 M phosphate buffer prt 6.8 1000 ml

Apparatus 2: 75 rpm.

Times: 2, 4, 8, and 14 hours.

Procedure—Determine the amount of C H NO dissolved by employing UV absorption at the wavelength of maximum absorbance at about 278 nm on portions of the solution under test passed through a 10-μm polyethylene filter, suitably diluted with Medium, if necessary, in
comparison with a Standard solution having a known concentration of USP Etodolac RS in the same Medium. Use Medium as the blank, and use a 0.05-cm silica cell.
Tolerances—The percentages of the labeled amount of C H NO dissolved at the times specified conform to Acceptance Table 2.

test 4-if the product complies with this test, the labeling indicates that it meets USP Dissolution Test 4.

Medium: 0.05 M phosphate buffer, pH 6.8; 900 mL.

Apparatus 275 rpm, with a wire a siker

Times: 2, 4, 8, and 18 hours.

Tour sciution-Pass a portion of the solution under sent through a suitable 70 um filter

Standard solution From a solution containing about 4 mg per mL of USP Etodolac RS in Mobile phase, make dilutions with Medium to obtain a solution with a final concentration of about 1/1500 mg per mil, where in the tablet label clam, in mg.

Mobile pluse-Prepare a filtered and degasaad mixture of actonitrila, water, and concentrated phosphoric acid (5000:500:0.25). Маке adjustments if necessary (see System Suitability under Chromatogranty(621).

Chisamatographic system (see (621) The liquid chromatograph is equipped with a 274-nm detector and 4.0-mm x 25-cm column that contains 5-um packing £1. The flow rate is about 1.5 nt, per minute. The column is maintained at 25. Chromatograph the Standard solution, and record the peak responses as directed for Procedure the relative standard deviation for replicate njactions is not more than 2.0%.

Procedure Separately inject equal volumes (about 10 µl.) of the Standant anlution and Test solution into the chromatograph, record the chromatograms, and measure the peak responses Calculate the percentage of stodolac dissolved at the times specified.

Tolerances-The persintages of the labeled amount of C H NO discolved at the times specified conform to Acceptance Table 2..

Uniformity of dosage units (905): meet the requirements.

Chromatographic purity—

Diluent, Mobile phase, and System sultahlilty solution-Proceed as directed in the Analy

Fest solution-Use the Assay preparation.

Chromatographic system-Prapore as directed in the Assay Chromatograph the System sumably solution, and record the peak responses as directed for Procedure: the relative retention times are about 0.8 for etodolac related compound A and 1.0 for etodolac, the resolution. R

between etodolac related compound A and etodolac is not less than 2.1 and the relative standard deviation for replicate injections is not more than 20%

Procedure-inject a volume (about 10 µl) of the fest solution atto the chromatograph, record the chromatogram, and measure al of the peak arese Calculate the percentage of each impunity in the portion of Tablets taken by the formula

100(r_i/r_s)

in which r_i is the peak ares for each impurity, and r_s is the sum of the areas of all the peaks: not more than 0.21% of any individual impurity s found, and not more than 0.75% of total impurities is found.

Assay—

Diluent—Use acetonitrile.

Mobile phase—Prepare a filtered and degassed mixture of acetonitrile, water, and phosphoric acid (500:500:0.25). Make adjustments if necessary (see System Suitability under Chromatography 〈621〉).

System suitability solution—Dissolve accurately weighed quantities of USP Etodolac RS and USP Etodolac Related Compound A RS in Diluent, and quantitatively dilute with Diluent to obtain a solution having known concentrations of about 0.48 mg per mL and 0.05 mg per mL, respectively.

Standard preparation—Dissolve an accurately weighed quantity of USP Etodolac RS in Diluent, and quantitatively dilute with Diluent to obtain a solution having a known concentration of about 0.6 mg per mL.

Assay preparation—[Note—Do not finely powder Tablets.) Weigh and powder not fewer than 20 Tablets, and transfer an accurately weighed portion of the powder, equivalent to about 600 mg of etodolac, to a 200-ml volumetric flask. Add about 100 mL of Diluent, mix, and shake for 40 minutes by mechanical means. Dilute with Diluent to volume, and mix. Pass through a filter having a 0.45-µm porosity, discarding the first 3 ml of the filtrate. Transfer 2.0 mL of the filtrate to a 10-mi, volumetric flask, dilute with Diluent to volume, and mix.

Chromatographic system (see Chromatography (621))-The liquid chromatograph is equipped with a 274-nm detector, a 4.0-mm x 4.0-cm guard column that contains 5-um packing 17, and a 4.0-mm 25-cm column that contains 5-um packing 17. The flow rate is about 1 mL per minute. Chromatograph the System suitability solution, and record the peak responses as directed for Procedure: the relative retention times are about 0.8 for etodolac related compound A and 1.0 for etodolac, the resolution, R, between etodolac related compound A and etodolac is not less than 2.5, and the tailing factor is not more than 2.0. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure, the relative standard deviation for replicate injections is not more than 2.0%.

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 quantity, in mg, of etodolac (CH, NO) in the portion of Tablets taken by the formula:

100(r_u/r_s)

in which C is the concentration, in mg per mL, of USP Etodolac RS in the Standard preparation; and r_u and r_s are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.