Prochlorperazine Oral Solution

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

Prochlorperazine Oral Solution contains an amount of Prochlorperazine Edisylate equivalent to NLT 92.0% and NMT 108.0% of the labeled amount of prochlorperazine (C₂₀H₂₄ClN₃S).

[Note—Throughout the following procedures, protect the sample, the Reference Standard, and solutions containing them, by conducting the procedures without delay, under subdued light, or using low-actinic glassware.]

2 IDENTIFICATION

A.

Analysis: To 2 mL of Oral Solution add 3 mL of water and 3 or 4 drops of ferric chloride TS.

Acceptance criteria: A stable red color is produced.

B.

Analysis: To 1 mL of Oral Solution add 10 mL of bromine TS, previously warmed to room temperature.

Acceptance criteria: Essentially no color change occurs (distinction from Chlorpromazine hydrochloride, which immediately produces a green color).

3 ASSAY

Procedure

Ion-pairing solution: Dissolve 4.33 g of sodium 1-octanesulfonate in 500 mL of water. Add 4.0 mL of glacial acetic acid, and dilute with water to 1 L.

Mobile phase: Acetonitrile, methanol, and Ion-pairing solution (40:10:50)

Diluent: A mixture containing 1000 mL of distilled water, 8.6 mL of concentrated hydrochloric acid, and 1000 mL of methanol

Internal standard solution: 0.9 mg/mL of trifluoperazine hydrochloride in Diluent

Standard stock solution: 1.0 mg/mL of USP Prochlorperazine Maleate RS in Diluent

Standard solution: 0.09 mg/mL of trifluoperazine hydrochloride from Internal standard solution and 0.1 mg/mL of USP Prochlorperazine Maleate RS from Standard stock solution, in Diluent

Sample solution: Transfer a quantity of Oral Solution, equivalent to 10.0 mg of prochlorperazine, to a 100-mL volumetric flask, add 10.0 mL of the Internal standard solution, and dilute with Diluent to volume.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 254 nm

Column: 3.9-mm × 15-cm; 10-µm packing L1

Flow rate: 1.5 mL/min

Injection volume: 10 µL

System suitability

Sample: Standard solution

[Note—The relative retention times for prochlorperazine and trifluoperazine are 1.0 and 1.3, respectively.]

Suitability requirements

Resolution: NLT 2.0 between prochlorperazine and the internal standard

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of prochlorperazine (C₂₀H₂₄ClN₃S) in the portion of Oral Solution taken:

Result = (Rᵤ / Rₛ) × (Cₛ / Cᵤ) × (Mᵤ / Mₛ) × 100

Rᵤ = peak response ratio of prochlorperazine to the internal standard from the Sample solution

Rₛ = peak response ratio of prochlorperazine to the internal standard from the Standard solution

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

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

Mᵤ = molecular weight of prochlorperazine, 373.94

Mₛ = molecular weight of prochlorperazine maleate, 606.09

Acceptance criteria: 92.0%–108.0%

4 PERFORMANCE TESTS

Deliverable Volume 〈698〉: Meets the requirements for Oral Solution packaged in multi-unit containers

Uniformity of Dosage Units 〈905〉: Meets the requirements for Oral Solution packaged in single-unit containers

5 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight, light-resistant containers.

USP Reference Standards 〈11〉

USP Prochlorperazine Maleate RS