Amoxicillin Capsules
»Amoxicillin Capsules contain the equivalent of not less than 90.0percent and not more than 120.0percent of the labeled amount of amoxicillin (C16H19N3O5S).
Packaging and storage— Preserve in tight containers,and store at controlled room temperature.
Identification— Prepare a test solution containing the equivalent of 4mg of amoxicillin per mLby adding 0.1Nhydrochloric acid to powder from Amoxicillin Capsules.Prepare a Standard solution of USP Amoxicillin RSin 0.1Nhydrochloric acid containing 4mg per mL.Use within 10minutes after preparation.Apply separately 5µLof each solution on a thin-layer chromatographic plate coated with a 0.25-mm layer of chromatographic silica gel mixture (see Chromatography á621ñ).Place the plate in a suitable chromatographic chamber,and develop the chromatogram in a solvent system consisting of a mixture of methanol,chloroform,water,and pyridine (90:80:30:10).When the solvent front has moved about three-fourths of the length of the plate,remove the plate from the chamber,and dry with warm air for 10minutes.Locate the spots on the plate by spraying lightly with a solution of ninhydrin in alcohol containing 3mg per mL,and dry at 110for 15minutes:the RFvalue of the principal spot obtained from the test solution corresponds to that obtained from the Standard solution.
Dissolution á711ñ—
Medium: water;900mL.
Apparatus 1: 100rpm.
Time: 60minutes.
Procedure— Determine the amount of C16H19N3O5Sdissolved by employing UVabsorption at the wavelength of maximum absorbance at about 272nm on 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 Amoxicillin RSin the same Medium.
Tolerances— Not less than 80%(Q)of the labeled amount of C16H19N3O5Sis dissolved in 60minutes.
Uniformity of dosage units á905ñ: meet the requirements.
Water,Method Iá921ñ: not more than 14.5%.
Assay—
Diluent,Mobile phase,Standard preparation,and Chromatographic system— Prepare as directed in the Assayunder Amoxicillin.
Assay preparation— Remove,as completely as possible,the contents of not fewer than 20Capsules,and weigh accurately.Mix the combined contents,and transfer an accurately weighed quantity,equivalent to about 200mg of anhydrous amoxicillin,to a 200-mLvolumetric flask,add Diluentto volume,and mix.Sonicate if necessary to ensure complete dissolution.Pass a portion of this solution through a suitable filter of 1-µm or finer porosity,and use the filtrate as the Assay preparation.Use this solution within 6hours.
Procedure— Proceed as directed for Procedurein the Assayunder Amoxicillin.Calculate the quantity,in mg,of amoxicillin (C16H19N3O5S)in the portion of Capsules taken by the formula:
0.2CP(rU/rS),
in which the terms are as defined therein.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 144
Pharmacopeial Forum:Volume No.30(5)Page 1583
Phone Number:1-301-816-8335