» Cimetidine Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of cimetidine (C10H16N6S).
Packaging and storage Preserve in tight, light-resistant containers, at controlled room temperature.
USP Reference standards 11
Identification The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Medium: 0.01 N hydrochloric acid; 900 mL.
Apparatus 1: 100 rpm. A 20-mesh basket may be used for 800-mg strength Tablets.
Time: 15 minutes.
Procedure Determine the amount of C10H16N6S dissolved by employing UV absorption at the wavelength of maximum absorbance at about 218 nm on filtered portions of the solution under test, suitably diluted with Dissolution Medium, in comparison with a Standard solution having a known concentration of USP Cimetidine RS in the same Medium.
Tolerances Not less than 80% (Q) of the labeled amount of C10H16N6S is dissolved in 15 minutes.
Uniformity of dosage units 905: meet the requirements.
Mobile phase , Standard preparation, and Chromatographic systemProceed as directed in the Assay under Cimetidine.
Assay preparation Weigh and finely powder not fewer than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 100 mg of cimetidine, to a 250-mL volumetric flask. Add 50 mL of methanol, shake for 2 minutes, add 40 mL of water, sonicate for 15 minutes, dilute with water to volume, and mix. Transfer 5.0 mL of this solution to a 200-mL volumetric flask, dilute with Mobile phase to volume, and mix.
Procedure Separately inject equal volumes (about 50 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of cimetidine (C10H16N6S) in the portion of Tablets taken by the formula:
10C(rU / rS)in which the terms are as defined in the Assay under Cimetidine.
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USP35NF30 Page 2666Pharmacopeial Forum: Volume No. 32(1) Page 72