Bupropion Hydrochloride 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

Bupropion Hydrochloride Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO·HCl).

2 IDENTIFICATION

A. Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K

Sample: Crush 1 Tablet using a mortar and pestle. Prepare an approximate 1% (w/w) dispersion of the sample in potassium bromide.

Acceptance criteria: The Sample shows strong bands at about 1690, 1560, and 1240 cm⁻¹ and a weaker band at about 740 cm⁻¹, similar to the reference preparation.

B. The retention time 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

Buffer: 6.8 g/L of monobasic potassium phosphate and 1.164 g/L of sodium hydroxide in water

Mobile phase: Methanol and Buffer (65:35)

Diluent: Methanol and water (65:35)

Standard solution: 0.6 mg/mL of USP Bupropion Hydrochloride RS in Diluent

Sample stock solution: Nominally 3.0 mg/mL of bupropion hydrochloride in Diluent prepared as follows. Transfer an appropriate number of Tablets to a suitable volumetric flask. Add 50% of the flask volume of Diluent, and shake by mechanical means until the Tablets have disintegrated (30–60 min). Sonicate for 5 min, dilute with Diluent to volume, and mix. Allow to stand for at least 30 min. Use the supernatant.

Sample solution: Nominally 0.6 mg/mL of bupropion hydrochloride from the Sample stock solution in Diluent

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 224 nm

Column: 4.6-mm × 15-cm; 5-µm base-deactivated packing L1

Flow rate: 1.2 mL/min

Injection volume: 10 µL

Run time: NLT 1.5 times the retention time of bupropion▲ (USP 1-Aug-2021)

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2.5

Relative standard deviation: NMT ▲1.0%▲ (USP 1-Aug-2021)

Analysis

Samples: Standard solution and Sample solution▲ (USP 1-Aug-2021)

Calculate the percentage of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO·HCl) in the portion of Tablets taken:

Result = (r₁/r₂) × (C₁/C₂) × 100

r₁ = peak area from the Sample solution

r₂ = peak area from the Standard solution

C₁ = concentration of USP Bupropion Hydrochloride RS in the Standard solution (mg/mL)

C₂ = nominal concentration of bupropion hydrochloride in the Sample solution (mg/mL)

Acceptance criteria: 90.0%–110.0%

4 PERFORMANCE TESTS

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Dissolution 〈711〉

Medium: Water; 900 mL

Apparatus 2: 50 rpm

Time: 45 min

Standard solution: USP Bupropion Hydrochloride RS at a known concentration in 0.1 N hydrochloric acid

Sample solution: Pass a portion of the solution under test through a suitable filter, and dilute with 0.1 N hydrochloric acid, if necessary.

Instrumental conditions

Mode: UV

Analytical wavelength: 252 nm

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO·HCl) dissolved:

Result = (A₁/A₂) × D × V × (1/L) × 100

A₁ = absorbance of the Sample solution

A₂ = absorbance of the Standard solution

D = dilution factor for the Sample solution, if necessary

V = volume of Medium, 900 mL

L = label claim (mg/Tablet)▲ (USP 1-Aug-2021)

Tolerances: NLT 80% (Q) of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO·HCl) is dissolved.

Uniformity of Dosage Units 〈905〉: Meet the requirements

5 ADDITIONAL REQUIREMENTS

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Packaging and Storage: Preserve in tight containers. ▲Store at controlled room temperature.▲ (USP 1-Aug-2021)

USP Reference Standards 〈11〉

USP Bupropion Hydrochloride RS