Labetalol Hydrochloride Tablets
» Labetalol Hydrochloride Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of labetalol hydrochloride (C19H24N2O3·HCl).
Packaging and storage
Preserve in tight, light-resistant containers, at a temperature between 2 and 30.
Identification
The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that of the Standard preparation, as obtained in the Assay.
Dissolution 711
Medium:
water; 900 mL.
Apparatus 2:
50 rpm.
Time:
45 minutes.
Procedure
Determine the amount of C19H24N2O3·HCl dissolved from UV absorbances at the wavelength of maximum absorbance at about 302 nm of filtered portions of the solution under test, suitably diluted with water, if necessary, in comparison with a Standard solution having a known concentration of USP Labetalol Hydrochloride RS in the same Medium.
Tolerances
Not less than 80% (Q) of the labeled amount of C19H24N2O3·HCl is dissolved in 45 minutes.
Uniformity of dosage units 905:
meet the requirements.
Assay
Mobile phase
, Standard preparation, and Chromatographic systemProceed as directed in the Assay under Labetalol Hydrochloride.
Assay preparation
Transfer an accurately counted number of Tablets, equivalent to about 2000 mg of labetalol hydrochloride, to a 500-mL volumetric flask, add 200 mL of water, and shake by mechanical means for 60 minutes. Dilute with water to volume, and mix. Filter the solution through a filter of 0.5 µm or finer porosity, discarding the first few mL of the filtrate. Transfer 10.0 mL of the filtrate to a 100-mL volumetric flask, dilute with Mobile phase to volume, and mix.
Procedure
Separately inject equal volumes (about 5 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the area responses for the major peaks. Calculate the quantity, in mg, of labetalol hydrochloride (C19H24N2O3·HCl) in each Tablet taken by the formula:
5000(C / N)(rU / rS)
in which C is the concentration, in mg per mL, of USP Labetalol Hydrochloride RS in the Standard preparation; N is the number of Tablets taken; and rU and rS are the peak area responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information
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Chromatographic Column
USP32NF27 Page 2744
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
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