Oxprenolol Hydrochloride Tablets
»Oxprenolol Hydrochloride Tablets contain not less than 90.0percent and not more than 110.0percent of the labeled amount of oxprenolol hydrochloride (C15H23NO3·HCl).
Packaging and storage—
Preserve in well-closed,light-resistant containers.
Identification—
Transfer a portion of powdered Tablets,equivalent to about 100mg of oxprenolol hydrochloride,to a suitable test tube containing 5mLof water.Shake this mixture for about 1minute and allow it to settle.Use the clear supernatant as the test solution.Prepare a Standard solution containing 20mg of USP Oxprenolol Hydrochloride RSper mL.Apply separate 1-µLportions of the test solution and of the Standard solution to a suitable thin-layer chromatographic plate (see Chromatography á621ñ)coated with a 0.25-mm layer of chromatographic silica gel mixture.Line a suitable chromatographic chamber with filter paper,saturate the paper with the developing solvent consisting of a mixture of ethyl acetate,glacial acetic acid,and water (15:5:5),and allow to stand for about 30minutes.Place the plate in the chamber,and develop the chromatogram until the solvent front has moved about three-fourths of the length of the plate.Remove the plate from the chamber,and dry at 100
for 15minutes.Spray the plate uniformly with a detection reagent consisting of a freshly prepared mixture of equal volumes of potassium ferricyanide solution (1in 100)and ferric chloride solution (1in 5).Dry the plate in a current of warm air for about 5minutes.Examine the chromatograms in ordinary light:the RFvalue of the principal spot obtained from the test solution corresponds to that obtained from the Standard solution.
for 15minutes.Spray the plate uniformly with a detection reagent consisting of a freshly prepared mixture of equal volumes of potassium ferricyanide solution (1in 100)and ferric chloride solution (1in 5).Dry the plate in a current of warm air for about 5minutes.Examine the chromatograms in ordinary light:the RFvalue of the principal spot obtained from the test solution corresponds to that obtained from the Standard solution.
Dissolution á711ñ—
Medium:
0.1Nhydrochloric acid;900mL.
Apparatus 1:
100rpm.
Time:
30minutes.
Procedure—
Determine the amount of C15H23NO3·HCl dissolved from UVabsorbances at the wavelength of maximum absorbance at about 272nm of filtered portions of the solution under test,suitably diluted with Dissolution Medium,if necessary,in comparison with a Standard solution having a known concentration of USP Oxprenolol Hydrochloride RSin the same medium.
Tolerances—
Not less than 80%(Q)of the labeled amount of C15H23NO3·HCl is dissolved in 30minutes.
Uniformity of dosage units á905ñ:
meet the requirements.
Assay—
Weigh and finely powder not less than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 80mg of oxprenolol hydrochloride,to a 100-mLvolumetric flask.Add 80mLof a Diluting solvent,which consists of a mixture of methanol and 0.1Nhydrochloric acid (9:1),and shake by mechanical means for 1hour.Dilute with Diluting solventto volume,and mix.Filter,discarding the first 10mLof the filtrate,transfer 25.0mLof the clear filtrate to a 200-mLvolumetric flask,dilute with Diluting solventto volume,and mix.Concomitantly determine the absorbances of this assay solution and a Standard solution of USP Oxprenolol Hydrochloride RSin the same solvent having a known concentration of about 0.1mg per mLat the wavelength of maximum absorbance at about 274nm and,in addition,at 300nm,using Diluting solventas the blank.Calculate the quantity,in mg,of C15H23NO3·HCl in the portion of Tablets taken by the formula:
800C(AU/AS),
in which Cis the concentration,in mg per mL,of USP Oxprenolol Hydrochloride RSin the Standard solution,and AUand ASare the differences between the absorbances at 274nm and 300nm of the assay solution and the Standard solution,respectively.
Auxiliary Information—
Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(PA5)Pharmaceutical Analysis 5
USP28–NF23Page 1431
Phone Number:1-301-816-8305