» Praziquantel Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C19H24N2O2.
Packaging and storage Preserve in tight containers.
Identification Transfer a quantity of powdered Tablets, equivalent to about 30 mg of Praziquantel, to a centrifuge tube, add 5 mL of methanol, agitate for 5 minutes, and centrifuge. Use the clear supernatant as the test solution. Apply separately, as 1-cm wide bands, 10 µL each of the test solution and a Standard solution of USP Praziquantel RS in methanol containing 6 mg per mL to a thin-layer chromatographic plate (see Chromatography 621) 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 8 cm. Remove the plate from the chamber, air-dry, and examine under short-wavelength UV light: the RF value of the principal band in the chromatogram of the test solution corresponds to that obtained for the Standard solution.
Medium: 0.1 N hydrochloric acid containing 2.0 mg of sodium lauryl sulfate per mL; 900 mL.
Apparatus 2: 50 rpm.
Time: 60 minutes.
Standard preparation Dissolve an accurately weighed quantity of USP Praziquantel RS in methanol to obtain a solution having a known concentration of about L/90 mg per mL, L being the labeled quantity, in mg, of praziquantel in each Tablet. Transfer 5.0 mL of this solution to a 50-mL volumetric flask, dilute with Dissolution Medium to volume, and mix.
Procedure Determine the amount of C19H24N2O2 dissolved from UV absorbances at the wavelength of maximum absorbance at about 263 nm 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 C19H24N2O2 is dissolved in 60 minutes.
Uniformity of dosage units 905: meet the requirements.
Standard preparation Dissolve an accurately weighed quantity of USP Praziquantel RS in Mobile phase, and dilute quantitatively, and stepwise if necessary, with Mobile phase to obtain a solution having a known concentration of about 0.18 mg per mL.
Assay preparation Weigh and finely powder not less than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 150 mg of praziquantel, to a 100-mL volumetric flask, add 70 mL of Mobile phase, sonicate for 5 minutes, dilute with Mobile phase to volume, mix, and filter. Transfer 3.0 mL of the filtrate to a 25-mL volumetric flask, dilute with Mobile phase to volume, and mix.
Procedure Proceed as directed for Procedure in the Assay under Praziquantel. Calculate the quantity, in mg, of C19H24N2O2 in the portion of Tablets taken by the formula:
2500(C / 3)(rU / rS)in which C is the concentration, in mg per mL, of USP Praziquantel RS in the Standard preparation, and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information Please check for your question in the FAQs before contacting USP.Chromatographic Column
USP32NF27 Page 3363
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.