Labetalol Hydrochloride Compounded Oral Suspension

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

Labetalol Hydrochloride Compounded Oral Suspension contains NLT 90.0% and NMT 110.0% of the labeled amount of labetalol hydrochloride (C₁₉H₂₄N₂O₃ · HCl).

Prepare Labetalol Hydrochloride Compounded Oral Suspension 40 mg/mL as follows (see Pharmaceutical Compounding—Nonsterile

Preparations 〈795〉).

Place the required number of tablets in a suitable mortar and comminute to a fine powder, or use Labetalol Hydrochloride powder. Add 20 mL of the Vehicle, and mix to form a uniform paste. Add the Vehicle in small portions almost to volume. Transfer the contents of the mortar, stepwise and quantitatively, to a calibrated bottle. Add the Vehicle in portions to rinse the mortar, then add sufficient Vehicle to bring to final volume, and mix well.

2 ASSAY

Procedure

Mobile phase: Methanol and 0.1 M monobasic sodium phosphate (35:65). Filter, and degas.

Standard solution: 400 μg/mL of USP Labetalol Hydrochloride RS

Sample solution: Agitate the container of Oral Suspension for 30 min on a rotating mixer, remove a 5-mL sample, and store in a clear glass vial at −70° until analyzed. At the time of analysis, remove the sample from the freezer, allow it to reach room temperature, and mix with a vortex mixer for 30 s. Pipet 1.0 mL of the sample into a 100-mL volumetric flask, and dilute with Mobile phase to volume.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 230 nm

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

Flow rate: 1.3 mL/min

Injection volume: 20 μL

System suitability

Sample: Standard solution

[Note—The retention time for labetalol hydrochloride is about 7.5 min.]

Suitability requirements

Relative standard deviation: NMT 1.6% for replicate injections

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of labetalol hydrochloride (C₁₉H₂₄N₂O₃ · HCl) in the portion of Oral Suspension taken:

Result = (r_U/r_S)x(C_S/C_U) × 100

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution

C_S = concentration of USP Labetalol Hydrochloride RS in the Standard solution (μg/mL)

C_U = nominal concentration of labetalol hydrochloride in the Sample solution (μg/mL)

Acceptance criteria: 90.0%–110.0%

3 SPECIFIC TESTS

pH 〈791〉: 4.0–5.0

4 ADDITIONAL REQUIREMENTS

Packaging and Storage: Package in tight, light-resistant containers. Store at controlled room temperature, or in a refrigerator.

Beyond-Use Date: NMT 60 days after the date on which it was compounded when stored at controlled room temperature, or in a refrigerator

Labeling: Label it to state that it is to be well shaken, and to state the Beyond-Use Date.

USP Reference Standards 〈11〉

USP Labetalol Hydrochloride RS