Bendroflumethiazide Tablets
DEFINITION
Bendroflumethiazide Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of bendroflumethiazide (C15H14F3N3O4S2).
IDENTIFICATION
• The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
ASSAY
• 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
Mode:
LC
Detector:
UV 270 nm
Column:
4.6-mm × 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 = (rU/rS) × (CS/CU) × 100
| rU | = | = peak response from the Sample solution |
| rS | = | = peak response from the Standard solution |
| CS | = | = concentration of USP Bendroflumethiazide RS in the Standard solution (µg/mL) |
| CU | = | = nominal concentration of bendroflumethiazide in the Sample solution (µg/mL) |
Acceptance criteria:
90.0%–110.0%
PERFORMANCE TESTS
• Dissolution 
711
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.
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
905:
Meet the requirements
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight containers.
• USP Reference Standards 11
11
USP Bendroflumethiazide RS 
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Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Sujatha Ramakrishna, Ph.D.
Senior Scientific Liaison 1-301-816-8349 |
(SM22010) Monographs - Small Molecules 2 |
| 711 |
Margareth R.C. Marques, Ph.D.
Senior Scientific Liaison 1-301-816-8106 |
(GCDF2010) General Chapters - Dosage Forms |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 2316
Pharmacopeial Forum: Volume No. 35(5) Page 1106