Dolasetron Mesylate Compounded 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)

DOWNLOAD PDF HERE

1 DEFINITION

Dolasetron Mesylate Compounded Oral Solution contains NLT 90.0% and NMT 110.0% of the labeled amount of dolasetron mesylate (C₁₂H₂₀N₂O₃ · CH₄O₃S).

Prepare Dolasetron Mesylate Compounded Oral Solution 10 mg/mL as follows (see Pharmaceutical Compounding—Nonsterile Preparations 〈795〉).

Add Dolasetron Mesylate powder and 15 mL of Vehicle to a mortar, and mix. Add the Vehicle in small portions almost to volume, and mix thoroughly after each addition. Transfer the contents of the mortar, stepwise and quantitatively, to a calibrated bottle. Add enough Vehicle to bring to final volume, and mix.

2 ASSAY

PROCEDURE

Solution A: 0.05 M ammonium acetate adjusted with diluted ammonium hydroxide to a pH of 7.5

Mobile phase: Acetonitrile and Solution A (24:76). Filter, and degas.

Diluent: Acetonitrile and water (24:76)

Standard stock solution: 500 µg/mL of USP Dolasetron Mesylate RS in Diluent

Standard solution: 10 µg/mL of USP Dolasetron Mesylate RS from Standard stock solution in Mobile phase

Sample solution: 10 µg/mL of dolasetron mesylate prepared from Oral Solution and Diluent. Shake each sample thoroughly by hand for 15 s, centrifuge at 1000 rpm for 2 min, and use the supernatant.

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 280 nm

Column: 4.6-mm x 15-cm; 3-µm packing L10

Column temperature: 30°

Flow rate: 0.8 mL/min

Injection volume: 5 µL

System suitability

Sample: Standard solution

[NOTE-The retention time for dolasetron mesylate is about 6.9 min.]

Suitability requirements

Relative standard deviation: NMT 1.4% for replicate injections

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of dolasetron mesylate (C₁₂H₂₀N₂O₃ · CH₄O₃S) in the portion of Oral Solution taken:

Result = (r_u /r_s ) × (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 Dolasetron Mesylate RS in the Standard solution (µg/mL)

C_u = nominal concentration of dolasetron mesylate in the Sample solution (µg/mL)

Acceptance criteria: 90.0%–110.0%

3 SPECIFIC TESTS

PH (791): 3.6-4.6

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 90 days after the date on which it was compounded when stored at controlled room temperature, or in a refrigerator

LABELING: Label it to state the Beyond-Use Date.

USP REFERENCE STANDARDS (11)

USP Dolasetron Mesylate RS