Atenolol Injection
» Atenolol Injection is a sterile solution of Atenolol in Water for Injection. It contains a suitable buffering agent. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of atenolol (C14H22N2O3).
Packaging and storage— Preserve in single-dose or in multiple-dose containers, preferably of Type I glass, in a cool place or at controlled room temperature, protected from light. Avoid freezing.
A: The retention time of the main peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, obtained as directed in the Assay.
Solution: 10 µg of atenolol per mL.
Medium: methanol.
Bacterial endotoxins 85 It contains not more than 33.3 USP Endotoxin Units per mg of atenolol.
Sterility 71 It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
pH 791: between 5.5 and 6.5.
Particulate matter 788: meets the requirements for small-volume injections.
Citric acid buffer— Transfer 2.5 g of citric acid to a 500-mL volumetric flask, add 400 mL of water, and swirl to dissolve. Adjust the solution with 2 N sodium hydroxide to a pH of 6.0, dilute with water to volume, and mix.
Mobile phase— Dissolve 930 mg of sodium octyl sulfate in 740 mL of water, add 8 mL of 3.6 N sulfuric acid, mix, and pass through a 1-µm or finer porosity filter. To the filtrate add 250 mL of acetonitrile, mix, and degas. Make adjustments if necessary (see System Suitability under Chromatography 621).
Standard preparation— Transfer about 50 mg of USP Atenolol RS to a 100-mL volumetric flask, add 80 mL of Citric acid buffer, and sonicate for about 30 seconds to achieve dissolution. Dilute with Citric acid buffer to volume, and mix. Transfer 4.0 mL of this solution to a 10-mL volumetric flask, dilute with Citric acid buffer to volume, and mix. This solution contains about 0.2 mg of USP Atenolol RS per mL.
Assay preparation— Transfer an accurately measured volume of Injection, equivalent to 2 mg of atenolol, to a 10-mL volumetric flask, dilute with Citric acid buffer to volume, and mix.
Chromatographic system (see Chromatography 621)—The liquid chromatograph is equipped with a 275-nm detector and a 4.6-mm × 25-cm column that contains 5-µm packing L1. The flow rate is about 1.7 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the tailing factor is not more than 2, and the relative standard deviation for replicate injections is not more than 2.0%.
Procedure— Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the areas for the major peaks. Calculate the quantity, in mg, of C14H22N2O3 in each mL of the Injection taken by the formula:
10(C / V)(rU / rS)
in which C is the concentration, in mg per mL, of USP Atenolol RS in the Standard preparation; V is the volume, in mL, of Injection taken; and rU and rS are the atenolol peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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Topic/Question Contact Expert Committee
Monograph Sujatha Ramakrishna, Ph.D.
(MDCV05) Monograph Development-Cardiovascular
Reference Standards Lili Wang, Technical Services Scientist
85 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 1597
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.