Irbesartan Tablets

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 

Irbesartan Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of irbesartan (C₂₅H₂₈N₆O). 

2 IDENTIFICATION 

Change to read: 

Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K

Sample: Add 10 mL of methanol to 1 Tablet, and sonicate for 10 min. Pass the solution through a glass microfiber membrane filter of 0.45- µm pore size. Evaporate to dryness, using a stream of nitrogen. Mix approximately 1 mg of the residue and approximately 250 mg of potassium bromide to obtain a homogenous mixture. 

Acceptance criteria: The IR absorption spectrum of the Sample exhibits maxima only at the same wavelengths as that of a similarly prepared standard using USP Irbesartan RS. 

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 

Buffer: Dilute 5.5 mL of phosphoric acid in approximately 950 mL of water. Adjust by adding triethylamine, slowly and dropwise, to a pH of 3.0, and dilute with water to 1 L. 

Mobile phase: Acetonitrile and Buffer (400:600) 

System suitability solution: 0.1 mg/mL each of USP Irbesartan RS and USP Irbesartan Related Compound A RS in methanol Standard solution: 0.15 mg/mL of USP Irbesartan RS in methanol 

Sample solution: Nominally 0.15 mg/mL of irbesartan in methanol prepared as follows. To a suitable amount of irbesartan from NLT 5 powdered Tablets add methanol to ll about 75% of the volume of the flask. Sonicate for 15 min, stirring at 5-min intervals. Dilute with methanol to volume, and pass through a glass microfiber membrane filter of 0.45-µm pore size. 

Chromatographic system 

(See Chromatography 〈621〉, System Suitability.) 

Mode: LC 

Detector: UV 220 nm 

Column: 4.6-mm × 25-cm; packing L1 

Flow rate: 1 mL/min 

Injection volume: 15 µL 

System suitability 

Samples: System suitability solution and Standard solution 

Suitability requirements 

Resolution: NLT 2.0 between irbesartan and irbesartan related compound A, System suitability solution 

Relative standard deviation: NMT 1.5%, Standard solution 

Analysis 

Samples: Standard solution and Sample solution 

Calculate the percentage of the labeled amount of irbesartan (C₂₅H₂₈N₆O) in the portion of Tablets taken: 

Result = (r_U/r_S) × (C_S/C_U) x 100 

r_U = peak response of irbesartan from the Sample solution

r_S = peak response of irbesartan from the Standard solution 

C_S = concentration of USP irbesartan RS in the Standard solution (µg/mL) 

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

Acceptance criteria: 90.0%–110.0% 

4 PERFORMANCE TESTS 

Dissolution 〈711〉 

Medium: 0.1 N hydrochloric acid; 1000 mL 

Apparatus 2: 50 rpm 

Time: 20 min 

Standard solution: USP Irbesartan RS in Medium 

Sample solution: Sample per Dissolution 〈711〉. Pass the Sample solution through a suitable Acrylic copolymer on a nylon support filter1 of 0.45-µm pore size, and dilute with Medium, if necessary, to a concentration that is similar to the Standard solution. Instrumental conditions 

Mode: UV 

Analytical wavelength: 244 nm 

Analysis 

Samples: Standard solution and Sample solution 

Calculate the percentage of irbesartan (C₂₅H₂₈N₆O) dissolved: 

Result = (A_U/A_S) × (C_S/L) x 100 

A_U = peak response of irbesartan from the Sample solution

A_S = peak response of irbesartan from the Standard solution 

C_S = concentration of USP irbesartan RS in the Standard solution (µg/mL) 

L = label claim (mg/Tablet) 

V = volume of Medium, 1000 mL 

Tolerances: NLT 80% (Q) of the labeled amount of irbesartan (C₂₅H₂₈N₆O) is dissolved. 

Uniformity of Dosage Units 〈905〉: Meet the requirements 

5 IMPURITIES 

Organic Impurities 

Buffer, Mobile phase, System suitability solution, Standard solution, Sample solution, Chromatographic system, and System suitability: Proceed as directed in the Assay. 

Analysis 

Sample: Sample solution 

Calculate the percentage of each impurity in the portion of Tablets taken: 

Result = (r_U/r_T) × 100 

r_U = peak response of each impurity 

r_T = sum of the responses of all the peaks 

Acceptance criteria 

Irbesartan related compound A: NMT 0.2% 

Any other impurity: NMT 0.2% 

Total impurities: NMT 0.5% 

6 ADDITIONAL REQUIREMENTS 

Packaging and Storage: Preserve in well-closed containers. 

USP Reference Standards 〈11〉 

USP Irbesartan RS 

USP Irbesartan Related Compound A RS 

1-Pentanoylamino-cyclopentanecarboxylic acid [2′-(1H-tetrazol-5-yl)-biphenyl-4-ylmethyl]-amide. 

C₂₅H₂₆N₆O₂ 446.54 

1 A suitable filter is Acrodisc, manufactured by Gelman Sciences and distributed by Pall Corp. (www.pall.com).