Praziquantel Tablets

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 DEFINITION

Praziquantel Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of C₁₉H₂₄N₂O₂.

2 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.

2.1 Chromatographic system

(See Chromatography 〈621〉, Thin-Layer Chromatography.)

Adsorbent: 0.25-mm layer of chromatographic silica gel mixture

Application volume: 10 µL

Developing solvent system: Ethyl acetate

2.2 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 R value of the principal band of the Sample solution corresponds to that of the Standard solution. F

3 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.

3.1 Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

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

3.2 System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 1.5

Relative standard deviation: NMT 1.0%

3.3 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of C₁₉H₂₄N₂O₂ in the portion of Tablets taken:

Result = (r_U /r_S ) × (C_S /C_U ) × 100

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution

C_S = concentration of USP Praziquantel RS in the Standard solution (mg/mL)

C_U = nominal concentration of praziquantel in the Sample solution (mg/mL)

Acceptance criteria: 90.0%–110.0%

4 PERFORMANCE TESTS

Change to read:

Dissolution 〈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 apex (ERR 1-Nov-2020) 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.

4.1 Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

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

4.2 System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 1.5

Relative standard deviation: NMT 2.0%

4.3 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of praziquantel dissolved in the portion of Tablets taken:

Result = (r_U /r_S ) × C_S × (V/L) × 100

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution

C_S = 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

5 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight containers.

USP Reference Standards 〈11〉

USP Praziquantel RS