Etodolac Tablets
» Etodolac 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 tight containers.
USP Reference standards 11
USP Etodolac RS Click to View Structure
USP Etodolac Related Compound A RS
(±)-8-Ethyl-1-methyl-1,3,4,9-tetrahydropyrano [3,4-b]-indole-1-acetic acid.
    C16H19NO3    273.33
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.
Uniformity of dosage units 905: meet the requirements.
Dissolution 711
Medium: pH 6.8 Phosphate buffer (see Buffer Solutions in the section Reagents, Indicators, and Solutions); 1000 mL.
Apparatus 1: 100 rpm.
Time: 30 minutes.
Procedure— Determine the amount of C17H21NO3 dissolved from UV absorbances at the wavelength of maximum absorbance at about 274 nm of filtered portions of the solution under test, suitably diluted with Dissolution Medium, if necessary, in comparison with a Standard solution having a known concentration of USP Etodolac RS in the same Medium.
Tolerances— Not less than 80% (Q) of the labeled amount of C17H21NO3 is dissolved in 30 minutes.
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 suitable quantities of USP Etodolac Related Compound A RS and USP Etodolac RS in Mobile phase to obtain a solution containing about 0.01 mg of etodolac related compound A and 0.2 mg of etodolac per mL.
Standard preparation— Dissolve an accurately weighed quantity of USP Etodolac RS in Mobile phase to obtain a solution having a known concentration of about 0.2 mg per mL. Prepare this solution fresh daily.
Assay preparation— Weigh and finely powder not less than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 1000 mg of etodolac, to a 500-mL volumetric flask, add 300 mL of Mobile phase, shake for 15 minutes, sonicate for 5 minutes, cool, dilute with Mobile phase to volume, and mix. Allow to settle for 10 minutes. Pipet 10.0 mL of the solution to a 100-mL volumetric flask, dilute with Mobile phase to volume, and mix. Pass the solution through a filter having a porosity of 0.45 µm or less.
Chromatographic system (see Chromatography 621)—The liquid chromatograph is equipped with a 274-nm detector and a 4.6-mm × 25-cm column that contains packing L1. The flow rate is about 1.5 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; the tailing factor is not more than 2; and the relative standard deviation for replicate injections is not more than 2%.
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 (C17H21NO3) in the portion of Tablets taken by the formula:
5000C(rU / rS)
in which C is the concentration, in mg per mL, of USP Etodolac RS in the Standard preparation; and rU and rS are the etodolac peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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Topic/Question Contact Expert Committee
Monograph Clydewyn M. Anthony, Ph.D.
Senior Scientific Liaison
(SM22010) Monographs - Small Molecules 2
Reference Standards RS Technical Services
711 Margareth R.C. Marques, Ph.D.
Senior Scientific Liaison
(GCDF2010) General Chapters - Dosage Forms
USP35–NF30 Page 3141