Etodolac 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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1 DEFINITION

Etodolac Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of etodolac (C₁₇H₂₁NO₃).

2 IDENTIFICATION

A. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

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AB. The UV spectrum of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

3 ASSAY

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PROCEDURE

Mobile phase: Acetonitrile phosphoric acid, and water (50:0.025:50)

Systern suitability solution: 0.01 mg/mL of USP Etodolac Related Compound A.RS and 0.2 mg/mL of USP Etodolac RS in Mobile phase

Standard solution: 0.2 mg/mL of USP Etodolac RS in Mobile phase. Prepare this solution fresh daily.

Sample stock solution: Nominally 2 mg/mL of etodolac prepared as follows. Transfer a portion of finely powdered Tablets (NLT 20), equivalent to about 1000 mg of etodolac, to a 500-ml. volumetric flask, add 300 ml of Mobile phase, shake for 15 min, and sonicate for 5 min. Cool, and dilute with Mobile phase to volume. Allow to settle for 10 min.

Sample solution: Nominally 0.2 mg/mL of etodolac in Mobile phase, from Sample stock solution. Pass the solution through a suitable filter of 0.45-um or finer pore size.

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 274 nm. For Identification B, use a diode array detector in the range of 190-400 nm (USP 1-May-2024)

Column: 4.6-mm × 25-cm; 10-μm packing L1

Flow rate: 1.5 mL/min

Injection volume: 10 µL

System suitability

Samples: System suitability solution and Standard solution

[NOTE-The relative retention times for etodolac related compound A and etodolac are 0.8 and 1.0, respectively.]

Suitability requirements

Resolution: NLT 2 between etodolac related compound A and etodolac, System suitability solution

Tailing factor: NMT 2, Standard solution

Relative standard deviation: NMT 2%, Standard solution

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of etodolac (C₁₇H₂₁NO₃) in the portion of Tablets taken:

Result = (r_U/(r_S) × (C_S /C_U) x 100

r_U = peak response of etodolac from the Sample solution

r_S = peak response of etodolac from the Standard solution

C_S = concentration of USP Etodolac RS in the Standard solution (mg/mL)

C_U = concentration of Etodolac in the Sample solution (mg/mL)

Acceptance criteria: 90.0%-110.0%

4 PERFORMANCE TESTS

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Dissolution (711)

Medium: 168 smoschate buffer 1000 ml

Apparatus 1: 100 rpm

Time: 30 min

Standard solution: A known concentration of USP Etodolac RS in Medium

Sample solution: Pass the solution under test through a suitable fiter. Dilute with Medium, if necessary to a suitable concentration that is similar to that of the Standart sin

Instrumental conditions

Mode: UV

Analytical wavelength Maximum at about 274 nm

Analysis

Samples: Standard solutur and Sample solution

Calculate the percentage of the labeled amount of etodolac (C₁₇H₂₁NO₃) dissolved:

Result = (A_u/A_s) x C_s x V x D x (1/L) x 100

A_u = absorbance of the Sample solution

A_s = absorbance of the Stansted ankhon

C_s = oncentration of USP Etodolac RS in the Standard solution (mg)

V = volume sit the Medium, 1000 mL

D = dilution factor of the Sample on

L = label claim (mg/Tablet)

Tolerances: NLT 80% (Q) of the labeled amount of etodolac (C₁₇H₂₁NO₃) is dissolved.

Uniformity of Dosage Units (905): Meet the requirements

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5 IMPURITIES

Protect the solutions containing etodolac from light

Solution A: 0.77 g/L of ammonium acetate in water

Solution B: Acetonitrile and Solution A (90:10)

Mobile phase: See Table Retum to original conditions and re-equilibrate the system. (Nars-Are-equilibration time of 15 min may be used.)

System suitability solution: 10 mg/mL of USP Etodolac RS and 0.002 mg/ml of USP Etodolan Related Comoound HRS in aortonte Sonicate to ikasobre as needed

Standard solution: 0.002 mg/ml, each of USP Etodolac RS and VIP Etodolac Related Compound RS acetonitiile Sonicate to dissolve as reeded

Sensitivity colution 1.0 µg/ml each of USP Etodolac RS and SUS Etodolac Related Compound 3182 acetamis, from the Standard solution

Sample solution: Nominally 1.0 mg/ml of etodolac prepared as follows: Transfer a portion of finery powdered Tablets (NLT 20), equent to about 50 mg of stodilac, to a 50-ml volumetric flack Add about 30 ml of acatanitik sonicate, and dilute with acutonitrile to volume. Non A senication tame of 15 min may be used

Chromatographic system

(See Chromatography (621), System Suitability.)

Moder LC

Detector: UV 225 nm

Column: 4.6 mm x 15 cm, 3.5 µm packing L26

Temperatures

Autosampler: 5°

Column: 35°

Flow rate: 1 ml/min

Injection volume: 5 μL

System suitability

Samples: System autability solution, Standard action, and Sevativity acution

Suitability requirements

Resolution: NLT 3.0 between etodolar and etodolac stated compound (ethyltrypthane, System surtably selection

Relative standard deviation: NMT 5.0% for etodolac and etodolac related compound (-ethyltrypthanol), Standard solution

Signal-to-noise ratio: NLT 10 for etodolac and etodolac related compound (7-ethyltrypthanol), Sensstiality solution

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of etodolac related compound (7-ethyltrypthanol) in the portion of Tablets taken:

Result = (r_U/(r_S) × (C_S /C_U) x 100

r_U = peak response of etidolac related compound H (7 ethyltrypthanol) from the Sample solution

r_S = peak response of etodolac related compound H (7-ethyltrypthanol) from the Standard solution

C_S = concentration of USP Etodolac Related Dumpound HRS in the Standan solution (mg/ml)

C_U = nominal concentration of etodolac in the Sample solution (mg/mL)

Caimulate the percentage of any unspecified degradation product in the portion of Tablets taken:

Result = (r_U/(r_S) × (C_S /C_U) x 100

r_U = peak response of any unspecified degradation product from the Sample solution

r_S = peak response of etodolac from the Standard solution

C_S = oncentration of USP Etodolac in the Standan solution (mg/ml)

C_U = nominal concentration of etodolac in the Sample solution (mg/mL)

Acceptance criteria: See Table 2. The reporting threshold is 0.1%.

6 ADDITIONAL REQUIREMENTS

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Packaging and Storage: Store at controlled room temperature in a tight, light-resistant container.