Telmisartan 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

Telmisartan Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of telmisartan (C₃₃H₃₀N₄O₂).

2 IDENTIFICATION

A. Spectroscopic Identification Tests 〈197〉, Ultraviolet-Visible Spectroscopy: 197U: The spectrum of the solution under test corresponds to that of the Standard solution, as obtained in Dissolution Test 1.

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

Change to read:

Procedure

Diluent: 0.005 N methanolic solution of sodium hydroxide

Buffer: 2.0 g/L of ammonium dihydrogen phosphate. Adjust with 1 M phosphoric acid to a pH of 3.0.

Mobile phase: Methanol and Buffer (70:30)

Standard stock solution: 0.8 mg/mL of USP Telmisartan RS and 0.1 mg/mL of USP Telmisartan Related Compound A RS in Diluent

Standard solution: 0.11 mg/mL of USP Telmisartan RS and 0.013 mg/mL of USP Telmisartan Related Compound A RS in Mobile phase from the Standard stock solution. Pass the solution through a membrane filter of 0.45-μm pore size.

Sample solution: Transfer NLT 20 Tablets into a suitable volumetric flask, and add about 80% of the volume of Diluent. Swirl to disperse, and sonicate for about 10 min. Allow to cool to room temperature, dilute with Diluent to volume, and mix. Pass the resulting solution through a membrane filter of 0.45-μm pore size. Further dilute quantitatively in Mobile phase to prepare a solution having a concentration of 0.11 mg/mL.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 298 nm

Column: 4.0-mm × 4-cm; 5-μm packing L1

Column temperature: 40°

Flow rate: 0.7 mL/min

Injection volume: 5 μL

System suitability

Sample: Standard solution

Suitability requirements

[Note—The relative retention times for telmisartan related compound A and telmisartan are 0.53 and 1.00, respectively.]

Resolution: NLT 3 between telmisartan and telmisartan related compound A

Tailing factor: NMT 2.0 for telmisartan (ERR 1-Nov-2023)

Relative standard deviation: NMT 2.0% for telmisartan (ERR 1-Nov-2023)

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of telmisartan in the portion of Tablets taken:

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U = peak response of telmisartan from the Sample solution

r_S = peak response of telmisartan from the Standard solution

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

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

Acceptance criteria: 90.0%–110.0%

4 PERFORMANCE TESTS

Change to read:

Dissolution 〈711〉

Test 1

Medium: pH 7.5 phosphate buffer (prepared by dissolving 13.61 g of potassium dihydrogen phosphate in about 800 mL of water, adjusting with 2 M sodium hydroxide to a pH of 7.5, and diluting with water to 1000 mL); 900 mL

Apparatus 2: 75 rpm

Time: 30 min

Standard solution: Transfer about 44 mg of USP Telmisartan RS to a 100-mL volumetric flask. Add 1 mL of 0.1 M sodium hydroxide, and dilute with methanol to volume. Dilute this solution quantitatively with Medium to obtain a solution having a final concentration of about 0.011 mg/mL.

Sample solution

For Tablets labeled to contain 20 mg: Pass a portion of the solution under test through a suitable filter of 0.45-μm pore size. Further dilute the filtrate with Medium (1:2).

For Tablets labeled to contain 40 mg: Pass a portion of the solution under test through a suitable filter of 0.45-μm pore size. Further dilute the filtrate with Medium (1:4).

For Tablets labeled to contain 80 mg: Pass a portion of the solution under test through a suitable filter of 0.45-μm pore size. Further dilute the filtrate with Medium (1:8).

Instrumental conditions

Mode: UV

Analytical wavelength: 296 nm

Blank: Medium

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount (ERR 1-Nov-2023) of telmisartan dissolved:

Result = (A_U/A_S) × C_S × V × D × (1/L) × 100 _{(ERR 1-Nov-2023)}

A_U = absorbance of the Sample solution

C_S = concentration of USP Telmisartan RS in (ERR 1-Nov-2023) the Standard solution (mg/mL)

V = volume of Medium, 900 mL

A_S = absorbance of the Standard solution

D = dilution factor of the Sample solution

L = label claim (mg/Tablet)

Tolerances: NLT 75% (Q) of the labeled amount of telmisartan is dissolved.

Test 2: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 2.

Medium: 0.1 N hydrochloric acid; 900 mL

Apparatus 2: 75 rpm

Time: 45 min

Buffer: 2.72 g/L of potassium dihydrogen phosphate. Add 2 mL of triethylamine per liter of solution and adjust with phosphoric acid to a pH of 2.4.

Mobile phase: Acetonitrile and Buffer (40:60)

Standard stock solution: 0.44 mg/mL of USP Telmisartan RS prepared as follows. To a suitable amount of USP Telmisartan RS in a suitable volumetric flask add methanol, about 50% of the total volume. Sonicate to dissolve, cool to room temperature, and dilute with Medium to volume.

Standard solution: (L/900) mg/mL of USP Telmisartan RS in Medium from Standard stock solution, where L is the label claim in mg/Tablet

Sample solution: Pass portions of the solution under test through a suitable filter of 0.45-μm pore size and discard the first 3 mL of the filtrate.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 298 nm

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

Flow rate: 1 mL/min

Injection volume: 20 μL

Run time: NLT 1.6 times the retention time of telmisartan

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of telmisartan dissolved:

Result = (r_U/r_S) × C_S × V × (1/L) × 100

r_U = peak response of telmisartan (ERR 1-Nov-2023) from the Sample solution

r_S = peak response of telmisartan (ERR 1-Nov-2023) from the Standard solution

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

V = volume of Medium, 900 mL

L = label claim (mg/Tablet)

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

Test 3: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 3.

Medium, Apparatus 2, and Instrumental conditions: Proceed as directed in Dissolution Test 1.

Time: 20 min

Standard solution: 0.011 mg/mL of USP Telmisartan RS prepared as follows. Transfer about 44 mg of USP Telmisartan RS to a 100-mL volumetric flask. Add 1 mL of 0.1 M sodium hydroxide, and sonicate to dissolve. Dilute with methanol to volume and mix. Dilute this solution quantitatively with Medium to obtain a solution of the required final concentration.

Sample solution: Pass a portion of the solution under test through a suitable filter of 0.45-μm pore size, and discard the first few milliliters.

Dilute quantitatively with Medium as needed.

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of telmisartan dissolved:

Result = (A_U/A_S) × C_S × V × D × (1/L) × 100

A_U = absorbance of the Sample solution

A_S = absorbance of the Standard solution

C_S = concentration of USP Telmisartan RS in (ERR 1-Nov-2023) the Standard solution (mg/mL)

V = volume of Medium, 900 mL

D = dilution factor of the Sample solution

L = label claim (mg/Tablet)

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

Uniformity of Dosage Units 〈905〉: Meet the requirements

5 IMPURITIES

Organic Impurities

Diluent, Buffer, Mobile phase, 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_S) × 100

r_U = peak response of each individual impurity from the Sample solution

r_S = peak response of telmisartan from the Sample solution

Acceptance criteria: NMT 0.2% of any individual impurity

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in well-closed containers, and store at controlled room temperature.

Labeling: When more than one Dissolution test is given, the labeling states the test used only if Test 1 is not used.

USP Reference Standards 〈11〉

USP Telmisartan RS

USP Telmisartan Related Compound A RS