Dobutamine Injection

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

Dobutamine Injection is a sterile solution of Dobutamine Hydrochloride in Water for Injection. It contains an amount of DobutamineHydrochloride equivalent to NLT 90.0% and NMT 110.0% of the labeled amount of dobutamine (C₁₈H₂₃NO₃). It may contain one or more suitable antioxidants, chelating agents, or preservatives.

2 IDENTIFICATION

A.

Standard solution: 10 mg/mL of USP Dobutamine Hydrochloride RS in methanol (freshly prepared)

Sample solution: Use the neat Injection.

Chromatographic system

(See Chromatography 〈621〉, Thin-Layer Chromatography.)

Mode: TLC

Adsorbent: 0.25-mm layer of chromatographic silica gel

Application volume: 10 μL

Developing solvent system: Ethyl acetate, n-propyl alcohol, glacial acetic acid, and water (100:40:5:15)

Analysis

Samples: Standard solution and Sample solution

Allow the spots to dry, and develop the chromatogram in the Developing solvent system, until the solvent front has moved about three-fourths of the length of the plate. Mark the solvent front, and allow it to evaporate at room temperature. Observe the plate under short-wavelength UV light.

Acceptance criteria: The R value of the principal spot of the Sample solution corresponds to that of the Standard solution.

3 ASSAY

Procedure

Ion-pair solution: Dissolve 3.38 g of sodium 1-octanesulfonate in 1 L of water, and pipet 3 mL of triethylamine into the solution. Adjust the solution with phosphoric acid to a pH of 2.5.

Mobile phase: Acetonitrile, methanol, and Ion-pair solution (28:14:58)

[Note—The ratio of acetonitrile to methanol is critical to the elution order of the System suitability solution components.]

System suitability solution: 0.3 mg/mL of 4-(4-hydroxyphenyl)-2-butanone and 0.56 mg/mL of USP Dobutamine Hydrochloride RS in Mobile phase

Standard solution: 0.56 mg/mL (equivalent to 0.5 mg/mL of dobutamine) of USP Dobutamine Hydrochloride RS in Mobile phase

Sample solution: Equivalent to a suitable volume of 0.5 mg/mL of dobutamine in Mobile phase, from Injection

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 280 nm

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

Flow rate: 1 mL/min

Injection volume: 20 μL

System suitability

Sample: System suitability solution

[Note—The relative retention times for 4-(4-hydroxyphenyl)-2-butanone and dobutamine are about 0.9 and 1.0, respectively.]

Suitability requirements

Resolution: NLT 1.5 between 4-(4-hydroxyphenyl)-2-butanone and dobutamine

Tailing factor: NMT 1.5 for dobutamine

Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of dobutamine (C₁₈H₂₃NO₃) in the portion of Injection taken:

Result = (r_U/r_S) × (C_S/C_U) × (M_r1/M_r2) × 100

r_U= peak response from the Sample solution

r_S= peak response from the Standard solution

C_S= concentration of USP Dobutamine Hydrochloride RS in the Standard solution (mg/mL)

C_U= nominal concentration of dobutamine in the Sample solution (mg/mL)

M_r1= molecular weight of dobutamine, 301.39

M_r2= molecular weight of dobutamine hydrochloride, 337.84

Acceptance criteria: 90.0%–110.0%

4 SPECIFIC TESTS

pH 〈791〉: 2.5–5.5

Injections and Implanted Drug Products 〈1〉: Meets the requirements

Particulate Matter in Injections 〈788〉: Meets the requirements for small-volume injections

Bacterial Endotoxins Test 〈85〉: It contains NMT 2.08 USP Endotoxin Units/mg of dobutamine.

5 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in single-dose or multiple-dose containers, preferably of Type I glass.

Labeling: Label it to indicate that it is to be diluted with a suitable parenteral vehicle to appropriate strength before administration.

USP Reference Standards 〈11〉

USP Dobutamine Hydrochloride RS