Dicyclomine Hydrochloride Tablets
» Dicyclomine Hydrochloride Tablets contain not less than 93.0 percent and not more than 107.0 percent of the labeled amount of dicyclomine hydrochloride (C19H35NO2·HCl).
Packaging and storage Preserve in well-closed containers.
USP Reference standards 11
A: Transfer a portion of finely powdered Tablets, equivalent to about 100 mg of dicyclomine hydrochloride, to a separator containing 10 mL of water and 1 mL of hydrochloric acid. Proceed as directed in Identification test A under Dicyclomine Hydrochloride Capsules, beginning with Extract the aqueous acid solution.
B: 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; 500 mL.
Apparatus 2: 50 rpm.
Time: 45 minutes.
Mobile phase, 0.04 M Phosphate buffer, pH 7.5, Bufferacetonitrile mixture, Test solution, and Chromatographic system Proceed as directed for Dissolution under Dicyclomine Hydrochloride Capsules.
Standard solution Prepare a solution in Medium having a known concentration of about 40 µg per mL of USP Dicyclomine Hydrochloride RS. Transfer 25.0 mL of this solution to a suitable flask, add 25.0 mL of the Bufferacetonitrile mixture, and mix.
Procedure Proceed as directed for Dissolution under Dicyclomine Hydrochloride Capsules.
Tolerances Not less than 75% (Q) of the labeled amount of C19H35NO2·HCl is dissolved in 45 minutes.
Uniformity of dosage units 905: meet the requirements.
0.02 M Phosphate buffer, pH 7.5, Mobile phase, Diluent, Standard preparation, and Chromatographic system Prepare as directed in the Assay under Dicyclomine Hydrochloride Capsules.
Assay preparation Transfer not fewer than 20 Tablets to a tared container, and determine the average Tablet weight. Grind the Tablets to a fine powder using a glass mortar and pestle. Transfer an accurately weighed portion of the powder, equivalent to about 20 mg of dicyclomine hydrochloride, to a 50-mL volumetric flask. Proceed as directed under Dicyclomine Hydrochloride Capsules beginning with Add 2.0 mL of water.
Procedure Proceed as directed in the Assay under Dicyclomine Hydrochloride Capsules. Calculate the quantity, in mg, of dicyclomine hydrochloride (C19H35NO2·HCl) in the portion of Tablets taken by the formula:
50C(rU / rS)in which C is the concentration, in mg per mL, of USP Dicyclomine Hydrochloride RS in the Standard preparation; and the other terms are as defined therein.
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USP35NF30 Page 2888Pharmacopeial Forum: Volume No. 30(3) Page 834