Dobutamine Hydrochloride

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 Hydrochloride contains NLT 98.0% and NMT 102.0% of dobutamine hydrochloride (C₁₈H₂₃NO₃ · HCl), calculated on the anhydrous basis.

[Caution—Great care should be taken to prevent inhaling particles of dobutamine hydrochloride and exposing the skin to it. Protect the eyes.]

2 IDENTIFICATION

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

B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

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C. Chloride (USP 1-Aug-2023)

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C. Identification Tests—General 〈191〉, Chemical Identification Tests, Chloride

Sample solution: 50 mg/mL of Dobutamine Hydrochloride in a mixture of water and methanol (50:50)

Analysis: Proceed as directed in the chapter using the procedure for amine hydrochlorides, except wash the precipitate with three 1-mL portions of water.

Acceptance criteria: Meets the requirements of the test for amine hydrochlorides (USP 1-Aug-2023)

3 ASSAY

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Procedure

Solutions containing dobutamine hydrochloride must be prepared fresh at the time of use and refrigerated until injected.

Solution A: Transfer 23 g of monobasic ammonium phosphate to a 2-L volumetric flask, and add 1900 mL of water. Adjust with phosphoric acid to a pH of 2.2, and dilute with water to volume.

Mobile phase: Acetonitrile and Solution A (20:80)

Standard solution: 0.5 mg/mL of USP Dobutamine Hydrochloride RS in water

Sample solution: 0.5 mg/mL of Dobutamine Hydrochloride in water

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 280 nm

Column: 3.9-mm × 30-cm; 15–20-μm packing L1. [Note—Alternatively, a column with 10-μm particle size may be used.] (USP 1-Aug-2023)

Flow rate: 1.5 mL/min

Injection volume: 20 μL

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 0.73%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of dobutamine hydrochloride (C₁₈H₂₃NO₃ · HCl) in the portion of Dobutamine Hydrochloride taken:

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U= peak response of dobutamine from the Sample solution

r_S= peak response of dobutamine from the Standard solution

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

C_U= concentration of Dobutamine Hydrochloride in the Sample solution (mg/mL)

Acceptance criteria: 98.0%–102.0% on the anhydrous basis

4 IMPURITIES

Residue on Ignition 〈281〉: NMT 0.2%

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Organic Impurities

Solution A: 2.6 g/L of sodium 1-octanesulfonate in water. Pipet 3 mL of triethylamine into 1 L of this solution. Adjust the solution with phosphoric acid to a pH of 2.5.

Solution B: Methanol and acetonitrile (82:18)

Diluent: Solution A and Solution B (50:50)

Mobile phase: See Table 1.

Table 1

Sensitivity solution: 1.25 μg/mL of USP Dobutamine Hydrochloride RS in Diluent

Standard solution: 0.025 mg/mL each of USP Dobutamine Related Compound C RS, USP Dopamine Hydrochloride RS, and USP Raspberry

Ketone RS; and 0.005 mg/mL of USP Dobutamine Hydrochloride RS in Diluent

Sample solution: 5 mg/mL of Dobutamine Hydrochloride in Diluent

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 280 nm

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

Flow rate: 1 mL/min

Injection volume: 20 μL

System suitability

Samples: Sensitivity solution and Standard solution

Suitability requirements

Resolution: NLT 1.5 between dopamine and raspberry ketone, Standard solution

Tailing factor: NMT 2.0 for dobutamine, Standard solution

Relative standard deviation: NMT 2.0% for dobutamine, Standard solution

Signal-to-noise ratio: NLT 10, Sensitivity solution

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of dopamine, raspberry ketone, and dobutamine related compound C (USP 1-Aug-2023) in the portion of Dobutamine Hydrochloride taken:

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U= peak response of dobutamine related compound C, dopamine, and raspberry ketone (USP 1-Aug-2023) from the Sample solution

r_S= peak response of dobutamine related compound C, dopamine, and raspberry ketone (USP 1-Aug-2023) from the Standard solution

C_S= concentration of the corresponding Reference Standard in the Standard solution (mg/mL)

C_U= concentration of Dobutamine Hydrochloride in the Sample solution (mg/mL)

Calculate the percentage of any (USP 1-Aug-2023) unspecified impurities in the portion of Dobutamine Hydrochloride taken:

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U= peak response of any (USP 1-Aug-2023) unspecified impurity from the Sample solution

r_S= peak response of dobutamine from the Standard solution

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

C_U= concentration of Dobutamine Hydrochloride in the Sample solution (mg/mL)

Acceptance criteria: See Table 2. The reporting threshold is 0.05%.

5 SPECIFIC TESTS

Water Determination 〈921〉, Method I: NMT 1.0%

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight containers. Store at controlled room temperature.

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USP Reference Standards 〈11〉

USP Dobutamine Hydrochloride RS

USP Dobutamine Related Compound C RS

N-(3,4-Dimethoxyphenethyl)-4-(4-methoxyphenyl)butan-2-amine hydrochloride.

C₂₁H₂₉NO₃ · HCl 379.93▲ (USP 1-Aug-2023)

USP Dopamine Hydrochloride RS

USP Raspberry Ketone RS

4-(4-Hydroxyphenyl)butan-2-one.

C₁₀H₁₂O₂ 164.20