Praziquantel Tablets
»Praziquantel Tablets contain not less than 90.0percent and not more than 110.0percent of the labeled amount of C19H24N2O2.
Packaging and storage— Preserve in tight containers.
Identification— Transfer a quantity of powdered Tablets,equivalent to about 30mg of Praziquantel,to a centrifuge tube,add 5mLof methanol,agitate for 5minutes,and centrifuge.Use the clear supernatant as the test solution.Apply separately,as 1-cm wide bands,10µLeach of the test solution and a Standard solution of USP Praziquantel RSin methanol containing 6mg per mLto a thin-layer chromatographic plate (see Chromatography á621ñ)coated with a 0.25-mm layer of chromatographic silica gel mixture.Develop the chromatogram in an unsaturated chamber,using ethyl acetate as the developing solvent,until the solvent front has moved about 8cm.Remove the plate from the chamber,air-dry,and examine under short-wavelength UVlight:the RFvalue of the principal band in the chromatogram of the test solution corresponds to that obtained for the Standard solution.
Dissolution á711ñ—
Medium: 0.1Nhydrochloric acid containing 2.0mg of sodium lauryl sulfate per mL;900mL.
Apparatus 2: 50rpm.
Time: 60minutes.
Standard preparation— Dissolve an accurately weighed quantity of USP Praziquantel RSin methanol to obtain a solution having a known concentration of about L/90mg per mL,Lbeing the labeled quantity,in mg,of praziquantel in each Tablet.Transfer 5.0mLof this solution to a 50-mLvolumetric flask,dilute with Dissolution Mediumto volume,and mix.
Procedure— Determine the amount of C19H24N2O2dissolved from UVabsorbances at the wavelength of maximum absorbance at about 263nm of filtered portions of the solution under test in comparison with the Standard preparation.
Tolerances— Not less than 75%(Q)of the labeled amount of C19H24N2O2is dissolved in 60minutes.
Uniformity of dosage units á905ñ: meet the requirements.
Assay—
Mobile phaseand Chromatographic system— Proceed as directed in the Assayunder Praziquantel.
Standard preparation— Dissolve an accurately weighed quantity of USP Praziquantel RSin Mobile phase,and dilute quantitatively,and stepwise if necessary,with Mobile phaseto obtain a solution having a known concentration of about 0.18mg per mL.
Assay preparation— Weigh and finely powder not less than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 150mg of praziquantel,to a 100-mLvolumetric flask,add 70mLof Mobile phase,sonicate for 5minutes,dilute with Mobile phaseto volume,mix,and filter.Transfer 3.0mLof the filtrate to a 25-mLvolumetric flask,dilute with Mobile phaseto volume,and mix.
Procedure— Proceed as directed for Procedurein the Assayunder Praziquantel.Calculate the quantity,in mg,of C19H24N2O2in the portion of Tablets taken by the formula:
2500(C/3)(rU/rS),
in which Cis the concentration,in mg per mL,of USP Praziquantel RSin the Standard preparation,and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1605
Phone Number:1-301-816-8394