Eprosartan Mesylate

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

Eprosartan Mesylate contains NLT 98.0% and NMT 101.5% of eprosartan mesylate (C₂₃H₂₄N₂O₄S · CH₄O₃S), calculated on the anhydrous and solvent-free basis.

2 IDENTIFICATION

Change to read:

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

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

3 ASSAY

Procedure

Mobile phase: Acetonitrile and water (22:78) containing 0.1% trifluoroacetic acid

Standard solution: 0.2 mg/mL of USP Eprosartan Mesylate RS in Mobile phase. Sonication may be necessary to dissolve.

Sample solution: 0.2 mg/mL of Eprosartan Mesylate in Mobile phase. Sonication may be necessary to dissolve.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 235 nm

Column: 4.6-mm × 15-cm; 5-μm packing L60

Column temperature: 40°

Flow rate: 1 mL/min

Injection volume: 20 μL

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 0.5%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of eprosartan mesylate (C₂₃H₂₄N₂O₄S · CH₄O₃S) in the portion of Eprosartan Mesylate taken:

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U = peak area of eprosartan from the Sample solution

r_S = peak area of eprosartan from the Standard solution

C_S = concentration of USP Eprosartan Mesylate RS in the Standard solution (mg/mL)

C_U = concentration of Eprosartan Mesylate in the Sample solution (mg/mL)

Acceptance criteria: 98.0%–101.5% on the anhydrous and solvent-free basis

4 IMPURITIES

Residue on Ignition 〈281〉: NMT 0.1%

Organic Impurities

Solution A: Use Mobile phase described in the Assay.

Solution B: Acetonitrile and water (40:60) containing 0.1% tri

uoroacetic acid

Mobile phase: See Table 1.

Table 1

Standard solution and Chromatographic system: Proceed as directed in the Assay.

Sensitivity solution: 0.2 μg/mL of USP Eprosartan Mesylate RS in Solution A from the Standard solution

Sample solution: 0.5 mg/mL of Eprosartan Mesylate in Solution A. Sonication may be necessary to dissolve.

System suitability: Proceed as directed in the Assay except for the Signal-to-noise ratio.

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

Analysis

Sample: Sample solution

Calculate the percentage of each impurity in the portion of Eprosartan Mesylate taken:

Result = (r_U/r_T) × 100

r_U = peak area of each impurity from the Sample solution

r_T = sum of all the peak areas from the Sample solution

Acceptance criteria: See Table 2. Disregard peaks below 0.03%.

Table 2

^a (E)-4-{[2-Butyl-5-(2-carboxyvinyl)-1H-imidazol-1-yl]methyl}benzoic acid.

^b 4-({2-Butyl-5-[2-carboxy-1-hydroxy-3-(thiophen-2-yl)propyl]-1H-imidazol-1-yl}methyl)benzoic acid.

Limit of Ethyl Methanesulfonate

Standard stock solution: 0.01 mg/mL of ethyl methanesulfonate in N,N-dimethylformamide

Standard solution: 0.004 μg/mL of ethyl methanesulfonate prepared as follows. Weigh 20 μL of Standard stock solution into a 50-mL volumetric flask and add 2 mL of N,N-dimethylformamide. Dilute with acetonitrile to volume, mix, and add 5 boiling stones.

Sensitivity solution: 0.00054 μg/mL of ethyl methanesulfonate in N,N-dimethylformamide from Standard solution

Sample solution: 20 mg/mL of Eprosartan Mesylate prepared as follows. Weigh about 1 g of Eprosartan Mesylate into a 50-mL volumetric flask, and pipette 2.0 mL of N,N-dimethylformamide into the flask. Dissolve and dilute with acetonitrile to volume, and mix. Add 5 boiling stones, allow the solution to precipitate for at least 2 h, and use the supernatant.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: GC-MS

Detector: Mass spectrometer, (+) ionization, a selected single-ion monitoring mode with m/z = 79 (CH SOOH+ion)

Column: 0.25-mm × 30-m; coated with a 0.25-μm layer of phase G27

Temperatures

Injection port: 160°

Column: See Table 3.

Table 3

Carrier gas: Helium

Flow rate: Constant pressure 46 kPa (0.9 mL/min at 50°)

Injection volume: 2 μL

Injection type: Split ratio, 1:4

System suitability

Samples: Standard solution and Sensitivity solution

Suitability requirements

Relative standard deviation: NMT 10%, Standard solution

Signal-to-noise ratio: NLT 2.5, Sensitivity solution

Analysis

Samples: Standard solution and Sample solution

Calculate the amount of ethyl methanesulfonate in the portion of Eprosartan Mesylate taken:

Result = (r_U/r_S) × (C_S/C_U) × 10⁶

r_U = peak response of ethyl methanesulfonate from the Sample solution

r_S = peak response of ethyl methanesulfonate from the Standard solution

C_S = concentration of ethyl methanesulfonate in the Standard solution (μg/mL)

C_U = concentration of Eprosartan Mesylate in the Sample solution (μg/mL)

Acceptance criteria: NMT 0.2 ppm

5 SPECIFIC TESTS

Water Determination 〈921〉, Method I: NMT 1.5%

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight containers and store at NMT 25°.

USP Reference Standards 〈11〉

USP Eprosartan Mesylate RS