Amikacin

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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C₂₂H₄₃N₅O₁₃ 585.60

D-Streptamine, O-3-amino-3-deoxy-α-d-glucopyranosyl-(1→6)-O-[6-amino-6-deoxy-α-d-glucopyranosyl-(1→4)]-N¹-(4-amino-2-hydroxy-1-oxobutyl)-2-deoxy-, (S)-;

O-3-Amino-3-deoxy-α-d-glucopyranosyl(1→4)-O-[6-amino-6-deoxy-α-d-glucopyranosyl(1→6)]-N³-(4-amino-l-2-hydroxybutyryl)-2-deoxy-l-streptamine CAS RN®: 37517-28-5; UNII: 84319SGC3C.

1 DEFINITION

Amikacin has a potency of NLT 900 μg/mg of amikacin (C₂₂H₄₃N₅O₁₃), calculated on the anhydrous basis.

2 IDENTIFICATION

Change to read:

A. Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K or 197A (CN 1-May-2020)

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

3 ASSAY

3.1 Procedure

Mobile phase: 134 mM sodium hydroxide, prepared as follows. Transfer a volume of deionized water to a suitable plastic container, sonicate, degas, and sparge with helium. While stirring, slowly add sodium hydroxide solution of a suitable concentration.

[Note-Prepare fresh daily. The Mobile phase readily absorbs carbon dioxide and produces carbonate that changes the retention time of amikacin. The use of a 50% (w/w), low-carbonate sodium hydroxide solution is recommended.]

System suitability solution: 0.02 mg/mL of USP Amikacin RS and 0.008 mg/mL of USP Kanamycin Sulfate RS in water

Standard solution: 0.02 mg/mL of USP Amikacin RS in water

Sample solution: 0.02 mg/mL of Amikacin in water

3.2 Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: Electrochemical

Mode: Integrated amperometric

Electrodes

Working: Gold

Reference: Silver-silver chloride

Detector settings: See Table 1.

Table 1

Column: 4-mm × 25-cm; 7.5-μm packing L47

[Note-A guard column of packing L47 is recommended.]

Flow rate: 0.5 mL/min

Injection volume: 20 μL

3.3 System suitability

Samples: System suitability solution and Standard solution

[Note-The relative retention times for kanamycin and amikacin are 0.8 and 1.0, respectively.]

3.4 Suitability requirements

Resolution: NLT 3 between kanamycin and amikacin, System suitability solution

Tailing factor: NMT 2, Standard solution

Relative standard deviation: NMT 3%, Standard solution

3.5 Analysis

Samples: Standard solution and Sample solution

Calculate the quantity, in μg, of amikacin (C₂₂H₄₃N₅O₁₃) in each mg of Amikacin taken:

Result = (r_u/r_s) × (C_s/C_u)× P × F

r_u = peak response of amikacin from the Sample solution

r_s = peak response of amikacin from the Standard solution

C_s = concentration of USP Amikacin RS in the Standard solution (mg/mL)

C_u = concentration of Amikacin in the Sample solution (mg/mL)

P = potency of amikacin in USP Amikacin RS (mg/mg)

F = conversion factor, 1000 μg/mg

Acceptance criteria: NLT 900 μg/mg on the anhydrous basis

4 IMPURITIES

Residue on Ignition 〈281〉: NMT 1.0%, the charred residue being moistened with 2 mL of nitric acid and 5 drops of sulfuric acid

5 SPECIFIC TESTS

Optical Rotation 〈781S〉, Procedures, Specific Rotation

Sample solution: 20 mg/mL in water

Acceptance criteria: +97° to +105°

Crystallinity 〈695〉: Meets the requirements

pH 〈791〉

Sample solution: 10 mg/mL in water

Acceptance criteria: 9.5–11.5

Water Determination 〈921〉, Method I: NMT 8.5%

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight containers.

USP Reference Standards 〈11〉

USP Amikacin RS

USP Kanamycin Sulfate RS