Pseudoephedrine Hydrochloride Tablets, chemical structure, molecular formula, Reference Standards

Pseudoephedrine Hydrochloride Tablets

»Pseudoephedrine Hydrochloride Tablets contain not less than 90.0percent and not more than 110.0percent of the labeled amount of pseudoephedrine hydrochloride (C10H15NO·HCl).

Packaging and storage— Preserve in tight containers.

USP Reference standards á11ñ— USP Pseudoephedrine Hydrochloride RS.

Identification—

A: Thin-Layer Chromatographic Identification Test á201ñ—

Test solution— Transfer 1tablet to a glass-stoppered tube,add 10mLof water,and shake or mix until the tablet completely disintegrates.Sonicate for 5minutes,centrifuge for 5minutes,and pass through a nylon filter.

Standard solution— Dissolve an accurately weighed quantity of USP Pseudoephedrine Hydrochloride RSin water to obtain a solution having a known concentration of about 3mg per mL.

Developing solvent system— Prepare a mixture of butyl alcohol,glacial acetic acid,and water (8:2:2).

Procedure— Proceed as directed in the chapter.The RFvalue and appearance of the principal spot obtained from the Test solutioncorrespond to that obtained from the Standard solution.

B: The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard solution,as obtained in the Assay.

Dissolution,Procedure for a Pooled Sample á711ñ—

Medium: water;900mL.

Apparatus 2: 50rpm.

Time: 45minutes.

Determine the amount of C10H15NO·HCl dissolved by employing the following method.

Mobile phase— Proceed as directed in theAssay.

Chromatographic system(see Chromatography á621ñ)— The liquid chromatograph is equipped with a 214-nm detector and a 4.6-mm ×25-cm column that contains packing L3.The flow rate is about 1.5mLper minute.Chromatograph the Standard solution,and record the peak responses as directed forProcedure:the tailing factor is not more than 2.0;and the relative standard deviation for replicate injections is not more than 2.0%.

Procedure— Inject a volume of a filtered portion of the solution under test into the chromatograph,record the chromatograms,and measure the responses for the major peaks.Calculate the quantity of C10H15NO·HCl dissolved in comparison with a Standard solution having a known concentration of USP Pseudoephedrine Hydrochloride RSin the same medium and similarly chromatographed.

Tolerances— Not less than 75%(Q)of the labeled amount of C10H15NO·HCl is dissolved in 45minutes.

Uniformity of dosage units á905ñ: meet the requirements,the following method being employed for chewable tablets.

PROCEDURE FOR CONTENT UNIFORMITY—

Mobile phaseand Chromatographic system— Proceed as directed in theAssay underPseudoephedrine Hydrochloride Syrup(Oral Solution,official June 1,2005).

Standard preparation— Dissolve an accurately weighed quantity of USP Pseudoephedrine Hydrochloride RSin a mixture of 0.01Nhydrochloric acid and methanol (4:1)to obtain a solution having a known concentration of about 0.15mg per mL.

Test preparation— Transfer 1Tablet,accurately weighed,into a 100-mLvolumetric flask,add 20mLof methanol,and shake for 30minutes.Add about 25mLof 0.01Nhydrochloric acid,and sonicate to dissolve.Cool to room temperature,dilute with 0.01Nhydrochloric acid to volume,mix,and filter.

Procedure— Proceed as directed in theAssay.

Assay—

Mobile phase,Standard preparation,and Chromatographic system— Proceed as directed in theAssay underPseudoephedrine Hydrochloride Syrup (Oral Solution,official June 1,2005).

Assay preparation— Weigh and finely powder not fewer than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 120mg of pseudoephedrine hydrochloride,to a 100-mLvolumetric flask,add 0.01Nhydrochloric acid,and sonicate to dissolve.Cool to room temperature.Dilute with 0.01Nhydrochloric acid to volume,mix,and filter.

Procedure— Separately inject equal volumes (about 10µL)of theStandard preparation and theAssay preparation into the chromatograph,record the chromatograms,and measure the responses for the major peaks.Calculate the quantity,in mg,of pseudoephedrine hydrochloride (C10H15NO·HCl)in the portion of Tablets taken by the formula:

100C(rU/rS),

in whichCis the concentration,in mg per mL,of USP Pseudoephedrine Hydrochloride RSin theStandard preparation;andrUandrSare the peak responses obtained from theAssay preparation and theStandard preparation,respectively.

Auxiliary Information— Staff Liaison:Daniel K.Bempong,Ph.D.,Scientist

Expert Committee:(PA2)Pharmaceutical Analysis 2

USP28–NF23Page 1672

Pharmacopeial Forum:Volume No.30(1)Page 172

Phone Number:1-301-816-8143