Atenolol Tablets
DEFINITION
Atenolol Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of atenolol (C14H22N2O3).
IDENTIFICATION
• A. Infrared Absorption 
197K
197K
Sample:
Mix a quantity of powdered Tablets, equivalent to 100 mg of atenolol, with 15 mL of methanol, heat the mixture to 50
, and shake for 5 min. Filter, and evaporate the filtrate on a water bath to dryness. Add 10 mL of 0.1 N hydrochloric acid to the residue, warm the solution, shake, and filter. To the filtrate add sufficient 1 N sodium hydroxide to make it alkaline, and extract the solution with 10 mL of chloroform, drying the chloroform extract over anhydrous sodium sulfate. Filter the dried chloroform solution, evaporate the filtrate on a water bath to dryness, and dry the residue at 105 for 1 h.
, and shake for 5 min. Filter, and evaporate the filtrate on a water bath to dryness. Add 10 mL of 0.1 N hydrochloric acid to the residue, warm the solution, shake, and filter. To the filtrate add sufficient 1 N sodium hydroxide to make it alkaline, and extract the solution with 10 mL of chloroform, drying the chloroform extract over anhydrous sodium sulfate. Filter the dried chloroform solution, evaporate the filtrate on a water bath to dryness, and dry the residue at 105 for 1 h.
• B.
The retention time of the atenolol peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
ASSAY
• Procedure
Mobile phase:
1.1 g of sodium 1-heptanesulfonate and 0.71 g of anhydrous dibasic sodium phosphate in 700 mL of water. Add 2 mL of dibutylamine, and adjust with 0.8 M phosphoric acid to a pH of 3.0. Add 300 mL of methanol, and pass through a filter having a 0.5-µm or finer porosity. Degas this solution before use.
Standard solution:
0.01 mg/mL of USP Atenolol RS in Mobile phase
Sample stock solution:
Transfer 10 Tablets to a 1000-mL volumetric flask. Add 500 mL of Mobile phase, and sonicate for 15 min to disintegrate the Tablets. Dilute with Mobile phase to volume.
Sample solution:
Centrifuge a portion of the Sample stock solution, and dilute a volume of the supernatant with Mobile phase to obtain a solution nominally containing 0.01 mg/mL of atenolol.
Chromatographic system
Mode:
LC
Detector:
UV 226 nm
Column:
3.9-mm × 30-cm; packing L1
Flow rate:
0.6 mL/min
Injection size:
10 µL
System suitability
Sample:
Standard solution
Suitability requirements
Column efficiency:
NLT 5000 theoretical plates
Tailing factor:
NMT 2.0
Relative standard deviation:
NMT 2.0%
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of C14H22N2O3 in each Tablet 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 Atenolol RS in the Standard solution (mg/mL) |
| CU | = | = nominal concentration of atenolol in the Sample solution (mg/mL) |
Acceptance criteria:
90.0%–110.0%
PERFORMANCE TESTS
• Dissolution 711
711
Medium:
0.1 N acetate buffer, pH 4.6 (prepared by mixing 44.9 parts (v/v) of 0.1 N sodium acetate with 55.1 parts (v/v) of 0.1 N acetic acid solution, and adjust with either diluted sodium hydroxide or diluted acetic acid to a pH of 4.6); 900 mL
Apparatus 2:
50 rpm
Time:
30 min
Determine the amount of C14H22N2O3 dissolved by using the following method.
Mobile phase, Chromatographic system, and System suitability:
Proceed as directed in the Assay under Atenolol.
Standard solution:
0.01 mg/mL of USP Atenolol RS in Mobile phase
Sample solution:
Pass a portion of the solution under test through a suitable 0.45-µm filter. Quantitatively dilute a measured volume of the filtrate with Mobile phase to obtain a solution estimated to contain about 0.01 mg/mL of atenolol.
Analysis:
Proceed as directed in the Assay.
Calculate the percentage of C14H22N2O3 dissolved:
Result = (rU/rS) × CS × V × D × (100/L)
| rU | = | = peak response from the Sample solution |
| rS | = | = peak response from the Standard solution |
| CS | = | = concentration of USP Atenolol RS in the Standard solution (mg/mL) |
| V | = | = volume of Medium, 900 mL |
| D | = | = dilution factor for the Sample solution |
| L | = | = Tablet label claim (mg) |
Tolerances:
NLT 80% (Q) of the labeled amount of C14H22N2O3 is dissolved.
• Uniformity of Dosage Units 905:
Meet the requirements
905:
Meet the requirements
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in well-closed containers.
• USP Reference Standards 11
11
USP Atenolol 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 2261
Pharmacopeial Forum: Volume No. 35(1) Page 66