Praziquantel Tablets
DEFINITION
Praziquantel Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of C19H24N2O2.
IDENTIFICATION
• Procedure
Standard solution:
6 mg/mL of USP Praziquantel RS in methanol
Sample solution:
Equivalent to 30 mg of Praziquantel from a quantity of powdered Tablets, in a centrifuge tube. Add 5 mL of methanol, agitate for 5 min, and centrifuge. Use the clear supernatant.
Chromatographic system
Adsorbent:
0.25-mm layer of chromatographic silica gel mixture
Application volume:
10 µL
Developing solvent system:
Ethyl acetate
Analysis
Samples:
Standard solution and Sample solution
Apply separately the Sample solution and Standard solution, each as 1-cm wide bands, to a chromatographic plate. Proceed as directed in the General Chapter. Develop the chromatogram in an unsaturated chamber, using developing solvent, until the solvent front has moved 8 cm. Remove the plate from the chamber, air-dry, and examine under short-wavelength UV light.
Acceptance criteria:
The RF value of the principal band of the Sample solution corresponds to that of the Standard solution.
ASSAY
• Procedure
Mobile phase:
Acetonitrile and water (3:2)
Standard solution:
0.18 mg/mL of USP Praziquantel RS in Mobile phase
Sample stock solution:
Weigh and finely powder NLT 20 Tablets. Transfer a portion of the powder, equivalent to 150 mg of praziquantel, to a 100-mL volumetric flask. Add 70 mL of Mobile phase, sonicate for 5 min, dilute with Mobile phase to volume, mix, and filter.
Sample solution:
Transfer 3.0 mL of the filtrate to a 25-mL volumetric flask, and dilute with Mobile phase to volume.
Chromatographic system
Mode:
LC
Detector:
UV 210 nm
Column:
4-mm × 25-cm; 10-µm packing L1
Flow rate:
1.5 mL/min
Injection size:
10 µL
System suitability
Sample:
Standard solution
Suitability requirements
Tailing factor:
NMT 1.5
Relative standard deviation:
NMT 1.0%
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of C19H24N2O2 in the portion of Tablets taken:
Result = (rU/rS) × (CS/CU) × 100
| rU | = | = peak response from the Sample solution |
| rS | = | = peak response from the Standard solution |
| CS | = | = concentration of USP Praziquantel RS in the Standard solution (mg/mL) |
| CU | = | = nominal concentration of praziquantel in the Sample solution (mg/mL) |
Acceptance criteria:
90.0%–110.0%
PERFORMANCE TESTS
• Dissolution 
711
711
For products for human use
Medium:
0.1 N hydrochloric acid containing 2.0 mg of sodium lauryl sulfate per mL; 900 mL
Apparatus 2:
50 rpm
Time:
60 min
Standard solution:
Prepare a solution of USP Praziquantel RS in methanol containing (L/90) mg/mL, where L is the Tablet label claim in mg. Transfer 5.0 mL of this solution to a 50-mL volumetric flask, and dilute with Medium to volume.
Sample solution:
Pass a portion of the solution under test through a suitable filter of 0.45-µm pore size.
Detector:
UV 263 nm
Blank:
Medium
Tolerances:
NLT 75% (Q) of the labeled amount of C19H24N2O2 is dissolved.
For products for veterinary use
Medium:
0.1 N hydrochloric acid containing 2.0 mg of sodium lauryl sulfate per mL; 900 mL
Apparatus 2:
50 rpm, with peak vessels
Time:
60 min
Mobile phase:
Acetonitrile and water (3:2)
Diluent:
Mix 600 mL of acetonitrile with 400 mL of pH 7.4 phosphate buffer.
Standard solution:
Prepare a solution containing 0.02 mg of USP Praziquantel RS per mL in methanol. Transfer 10.0 mL to a 100-mL volumetric flask, and dilute with Diluent to volume. Transfer 4.0 mL to a 100-mL volumetric flask, add 10 mL of 0.1 N hydrochloric acid, and dilute with Diluent to volume.
Sample solution:
Pass a portion of the solution under test through a suitable filter of 0.45-µm pore size.
Chromatographic system
Mode:
LC
Detector:
UV 210 nm
Column:
4.6-mm × 25-cm, 10-µm packing L1
Flow rate:
1.5 mL/min
Injection size:
20 µL
System suitability
Sample:
Standard solution
Suitability requirements
Tailing factor:
NMT 1.5
Relative standard deviation:
NMT 2.0%
Analysis:
Samples:
Standard solution and Sample solution
Calculate the percentage of praziquantel dissolved in the portion of Tablets taken:
Result = (rU/rS) × CS × (V/L) × 100
| rU | = | = peak response from the Sample solution |
| rS | = | = peak response from the Standard solution |
| CS | = | = concentration of the Standard solution (mg/mL) |
| V | = | = volume of Medium, 900 mL |
| L | = | = label claim (mg/Tablet) |
Tolerances:
NLT 75% (Q) of the labeled amount of C19H24N2O2 is dissolved
• Uniformity of Dosage Units 905:
Meet the requirements
905:
Meet the requirements
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight containers.
• USP Reference Standards 11
11
USP Praziquantel RS 
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Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Leonel M. Santos, Ph.D.
Senior Scientific Liaison 1-301-816-8168 |
(SM12010) Monographs - Small Molecules 1 |
| 711 |
Margareth R.C. Marques, Ph.D.
Senior Scientific Liaison 1-301-816-8106 |
(GCDF2010) General Chapters - Dosage Forms |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 4392
Pharmacopeial Forum: Volume No. 35(2) Page 291