Ibuprofen 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

Ibuprofen Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of ibuprofen (C₁₃H₁₈O₂).

2 IDENTIFICATION

A. The UV absorption spectra of the ibuprofen peak of the Sample solution exhibit maxima and minima at the same wavelengths as those of the Standard solution, as obtained in the Assay.

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

3 ASSAY

Procedure

Mobile phase: Dissolve 4.0 g of chloroacetic acid in 400 mL of water, adjust with ammonium hydroxide to a pH of 3.0 if necessary, add 600 mL of acetonitrile, and mix.

Standard solution: 10.0 mg/mL of USP Ibuprofen RS in Mobile phase

Sample solution: Nominally 10.0 mg/mL of ibuprofen prepared as follows. Transfer NLT 10 Tablets to a suitable volumetric flask and add about 50% final volume of Mobile phase. Shake on a mechanical shaker for at least 60 min or until the Tablets are disintegrated. Dilute with Mobile phase to volume. Centrifuge a portion of the solution at about 3000 rpm for about 10 min or until a clear supernatant is obtained. Use the supernatant for analysis.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

[Note—It is suggested to use the mixture of methanol and water (90:10) for needle wash.]

Mode: LC

Detectors

Assay: UV 254 nm

Identification test A: Diode array UV 200–400 nm

Column: 4.6-mm × 25-cm; 5-µm packing L1

Flow rate: 2.0 mL/min

Injection volume: 10 µL

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2.5

Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of ibuprofen (C₁₃H₁₈O₂) in the portion of Tablets taken:

Result = (rᵤ / rₛ) × (Cₛ / Cᵤ) × 100

rᵤ = peak response of ibuprofen from the Sample solution

rₛ = peak response of ibuprofen from the Standard solution

Cₛ = concentration of USP Ibuprofen RS in the Standard solution (mg/mL)

Cᵤ = nominal concentration of ibuprofen in the Sample solution (mg/mL)

Acceptance criteria: 90.0%–110.0%

4 PERFORMANCE TESTS

Dissolution 〈711〉

Medium: pH 7.2 phosphate buffer (see Reagents, Indicators, and Solutions—Buffers); 900 mL

Apparatus 2: 50 rpm

Time: 60 min

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

Sample solution: Filter a portion of the solution under test, and suitably dilute with Medium if necessary.

Instrumental conditions

Mode: UV

Analytical wavelength: Maximum absorbance at about 221 nm

Analysis: Determine the amount of ibuprofen (C₁₃H₁₈O₂) dissolved by comparing the UV absorbance of the Sample solution with that of the Standard solution.

[Note—Where the Tablets are labeled as gelatin-coated, determine the amount of ibuprofen (C₁₃H₁₈O₂) dissolved from the UV absorbance at the wavelength of maximum absorbance at about 266 nm, from which is subtracted the absorbance at 280 nm, in comparison with the Standard solution, similarly measured.]

Tolerances: NLT 80% (Q) of the labeled amount of ibuprofen (C₁₃H₁₈O₂) is dissolved.

Uniformity of Dosage Units 〈905〉: Meet the requirements

5 IMPURITIES

Organic Impurities

Mobile phase, Sample solution, and Chromatographic system: Proceed as directed in the Assay.

Sensitivity solution: 0.005 mg/mL of USP Ibuprofen RS in Mobile phase

System suitability solution: 10.0 mg/mL of USP Ibuprofen RS and 0.01 mg/mL each of USP Ibuprofen Related Compound C RS and USP Ibuprofen Related Compound J RS in Mobile phase

Standard solution: 0.02 mg/mL of USP Ibuprofen RS and 0.01 mg/mL each of USP Ibuprofen Related Compound C RS and USP Ibuprofen Related Compound J RS in Mobile phase

System suitability

Samples: Sensitivity solution, System suitability solution, and Standard solution

Suitability requirements

Resolution: NLT 2.5 between ibuprofen related compound J and ibuprofen; NLT 2.5 between ibuprofen and ibuprofen related compound C, System suitability solution

Signal-to-noise ratio: NLT 10, Sensitivity solution

Relative standard deviation: NMT 6.0% for ibuprofen related compound J, ibuprofen, and ibuprofen related compound C, Standard solution

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of ibuprofen related compound J and ibuprofen related compound C in the portion of Tablets taken:

Result = (rᵤ / rₛ) × (Cₛ / Cᵤ) × 100

rᵤ = peak response of ibuprofen related compound J or ibuprofen related compound C from the Sample solution

rₛ = peak response of ibuprofen related compound J or ibuprofen related compound C from the Standard solution

Cₛ = concentration of USP Ibuprofen Related Compound J RS or USP Ibuprofen Related Compound C RS in the Standard solution (mg/mL)

Cᵤ = nominal concentration of ibuprofen in the Sample solution (mg/mL)

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

Result = (rᵤ / rₛ) × (Cₛ / Cᵤ) × 100

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

rₛ = peak response of ibuprofen from the Standard solution

Cₛ = concentration of USP Ibuprofen RS in the Standard solution (mg/mL)

Cᵤ = nominal concentration of ibuprofen in the Sample solution (mg/mL)

Acceptance criteria: See Table 1. Disregard any peaks less than 0.05%.

Table 1

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in well-closed containers.

Labeling: Where the Tablets are gelatin-coated, the label so states.

USP Reference Standards 〈11〉

USP Ibuprofen RS

USP Ibuprofen Related Compound C RS

4-Isobutylacetophenone.

C₁₂H₁₆O 176.25

USP Ibuprofen Related Compound J RS

2-(4-Isobutyrylphenyl)propanoic acid.

C₁₃H₁₆O₂ 220.26