Bendroflumethiazide 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

Bendroflumethiazide Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of bendroflumethiazide (C₁₅H₁₄F₃N₃O₄S₂).

2 IDENTIFICATION

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

3.1 PROCEDURE

[NOTE-Use low-actinic glassware for the Sample solution and the Standard solution.]

Mobile phase: Dissolve 5.62 g of sodium chloride and 1.97 g of anhydrous sodium sulfate in 1000 mL of water in a 2-L volumetric flask. Add 4.0 mL of glacial acetic acid and 800 mL of methanol, and dilute with water to volume.

Standard solution: 50 µg/mL of USP Bendroflumethiazide RS in methanol

Sample solution: Nominally equivalent to 50 µg/mL from finely powdered Tablets (NLT 20). Initially add methanol (70% of the volume of the flask) and sonicate for 15 min with occasional shaking. Dilute further with methanol to the required concentration, and centrifuge for 15 min.

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 270 nm

Column: 4.6-mm x 30-cm; packing L11

Temperature: 35 ± 5°

Flow rate: 1.5 mL/min

Injection size: 20 µL

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 3.0% for five replicate injections

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of C₁₅H₁₄F₃N₃O₄S₂ in the portion of Tablets taken:

Result = (r_U/r_S) x (C_S/C_U) × 100

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution

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

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

Acceptance criteria: 90.0%-110.0%

4 PERFORMANCE TESTS

4.1 DISSOLUTION (711)

[NOTE-Protect solutions from light throughout this test.]

Medium: 0.01 N hydrochloric acid; 900 mL

Apparatus 2: 50 rpm

Time: 45 min

Detector: UV 271 nm

Sample solution: Sample per Dissolution (711).

Standard solution: Prepare a stock solution of USP Bendroflumethiazide RS in an appropriate organic solvent, and dilute this solution with Medium to obtain a final concentration similar to the one expected in the Sample solution.

Analysis: Determine the amount of C₁₅H₁₄F₃N₃O₄S₂ dissolved by using UV absorption on filtered portions of the Sample solution, suitably diluted with water, if necessary, in comparison with a Standard solution having a known concentration of USP Bendroflumethiazide RS.

Tolerances: NLT 75% (Q) of the labeled amount of C₁₅H₁₄F₃N₃O₄S₂ is dissolved.

UNIFORMITY OF DOSAGE UNITS (905): Meet the requirements

5 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Preserve in tight containers.

USP REFERENCE STANDARDS (11)

USP Bendroflumethiazide RS