Albendazole 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

Albendazole Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of albendazole (C₁₂H₁₅N₃O₂S).

2 IDENTIFICATION

A. Spectroscopic Identification Tests 〈197〉, Ultraviolet-Visible Spectroscopy: 197U

Acidified methanol: Prepare as directed in Dissolution Test 1.

Standard stock solution and Sample stock solution: Prepare as directed in the Assay.

Standard solution: About 10 µg/mL of albendazole in Acidified methanol, from Standard stock solution

Sample solution: About 10 µg/mL of albendazole in Acidified methanol, from Sample stock solution

Acceptance criteria: Meet the requirements

B. The retention time of the major peak for albendazole of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

3 ASSAY

3.1 Procedure

Mobile phase: Dissolve 0.50 g of monobasic ammonium phosphate in 400 mL of water. Add 600 mL of methanol, mix, and lter, discarding the first 15 mL of the filtrate. Degas the clear filtrate before use.

Solution A: Methanol and sulfuric acid (99:1)

Internal standard solution: 3 mg/mL of USP Parbendazole RS prepared as follows. Transfer 150 mg of USP Parbendazole RS to a 50-mL volumetric ask, add 5 mL of Solution A and 25 mL of methanol, and shake to dissolve. Dilute with methanol to volume and mix. Standard stock solution: 2 mg/mL of USP Albendazole RS prepared as follows. Transfer 100 mg of USP Albendazole RS to a 50-mL volumetric ask, add 5 mL of Solution A and 25 mL of methanol, and shake to dissolve. Dilute with methanol to volume and mix. Standard solution: 0.2 mg/mL of USP Albendazole RS and 0.3 mg/mL of USP Parbendazole RS in methanol, from Standard stock solution and Internal standard solution

Sample stock solution: Nominally 2 mg/mL of albendazole prepared as follows. Weigh and finely powder NLT 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 100 mg of albendazole, to a 50-mL volumetric ask. Add 5 mL of Solution A and 20 mL of methanol, and shake by mechanical means for about 15 min. Dilute with methanol to volume, mix, and filter, discarding the first 15 mL of the filtrate.

Sample solution: Nominally 0.2 mg/mL of albendazole and 0.3 mg/mL of USP Parbendazole RS in methanol, from Sample stock solution and Internal standard solution

3.2 Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 254 nm

Column: 4.6-mm × 25-cm; 5-µm packing L1

Flow rate: 2 mL/min

Injection volume: 20 µL

System suitability

Sample: Standard solution

Suitability requirements

Resolution: NLT 2.0 between albendazole and parbendazole

Column efficiency: NLT 1000 theoretical plates

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0%

3.3 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of albendazole (C₁₂H₁₅N₃O₂S) in the portion of Tablets taken:

Result = (R_U /R_S ) × (C_S /C_U ) × 100

R_U = peak height ratio of albendazole to parbendazole from the Sample solution  

R_S = peak height ratio of albendazole to parbendazole from the Standard solution

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

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

Acceptance criteria: 90.0%–110.0%

4 PERFORMANCE TESTS

Change to read:

Dissolution 〈711〉

Test 1 (RB 3-Mar-2021)

Medium: 0.1 N hydrochloric acid; 900 mL

Apparatus 2: 50 rpm

Time: 30 min

Acidified methanol: Methanol and hydrochloric acid (98:2)

Standard stock solution: 0.36 mg/mL of USP Albendazole RS prepared as follows. Dissolve about 90 mg of USP Albendazole RS, accurately weighed, in 10 mL of Acidified methanol in a 250-mL volumetric ask with shaking. Dilute with 0.1 N hydrochloric acid to volume.

Standard solution: 0.009 mg/mL of USP Albendazole RS in 0.1 N sodium hydroxide, from Standard stock solution Sample solution: Pass a portion of the solution under test through a suitable flasher. Prepare a 1-in-25 dilution of the dilute with 0.1 N sodium hydroxide.

Blank: 0.1 N sodium hydroxide

Instrumental conditions

Mode: UV

Analytical wavelengths: Maximum absorbance at about 308 nm and minimum absorbance at about 350 nm Analysis:

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of albendazole (C₁₂H₁₅N₃O₂S) dissolved:

Result = (A_U /A_S ) × (C_S /L) × V × D × 100

A_U = absorbance of Sample solution at about 308 nm − absorbance of Sample solution at about 350 nm

A_S = absorbance of Standard solution at about 308 nm − absorbance of Standard solution at about 350 nm

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

L = label claim (mg/Tablet)

V = volume of Medium, 900 mL

D = dilution factor of the Sample solution, 25

Tolerances: NLT 80% (Q) of the labeled amount is dissolved.

Test 2: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 2.

Medium: 0.1 N hydrochloric acid; 900 mL

Apparatus 2: 75 rpm

Time: 30 min

Determine the percentage of the labeled amount of albendazole (C H N O S) dissolved by using one of the following procedures. 12 15 3 2

Spectrophotometric procedure

Acidied methanol, Standard stock solution, Standard solution, Sample solution, Blank, Instrumental conditions, and Analysis: Proceed as directed in Dissolution Test 1.

[Note—If the absorbance at about 350 nm in the Sample solution is below zero, then consider the absorbance as zero.] Chromatographic procedure

Buffer: 1.05 g/L of potassium phosphate dibasic and 1.0 g/L of potassium phosphate monobasic in water Mobile phase: Acetonitrile, Buffer, and water (54: 40.5: 5.5)

Diluent: Methanol, water, and sulfuric acid (75:24:1)

Standard solution: 0.22 mg/mL of USP Albendazole RS prepared as follows. Transfer about 55.0 mg of USP Albendazole RS to a 250-mL volumetric ask. Add 10 mL of Diluent and sonicate to dissolve. Dilute with Medium to volume.

Sample solution: Pass a portion of the solution under test through a suitable lter.

4.1 Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 254 nm

Column: 4.6-mm × 15-cm; 5-µm packing L1

Column temperature: 40°

Flow rate: 1.5 mL/min

Injection volume: 5 µL

Run time: NLT 6 min

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 1.5

Relative standard deviation: NMT 2.0%

4.2 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of albendazole (C₁₂H₁₅N₃O₂S) dissolved:

Result = (r_U/r_S ) × C_S × V × (1/L) × 100

r_U = peak response of albendazole from the Sample solution  

r_S = peak response of albendazole from the Standard solution

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

V = volume of Medium, 900 mL

L = label claim (mg/Tablet)

Tolerances: NLT 80% (Q) of the labeled amount is dissolved. (RB 3-Mar-2021)

Uniformity of Dosage Units 〈905〉: Meet the requirements

Procedure for content uniformity (if applicable)

Acidified methanol and Standard solution: Prepare as directed in Dissolution Test 1.

Sample stock solution: Place 1 Tablet in a 500-mL volumetric ask, add about 300 mL of Acidified methanol, shake by mechanical means for about 30 min, and dilute with Acidified methanol to volume. Filter a portion of this solution, discarding the first 20 mL of trifiltrate. Sample solution: Transfer 4.0 mL of the Sample stock solution to a 200-mL volumetric ask, and dilute with 0.1 N sodium hydroxide to volume and mix.

Blank: 0.1 N sodium hydroxide

Instrumental conditions

Mode: UV

Analytical wavelengths: Maximum absorbance at about 308 nm and minimum absorbance at about 350 nm Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of albendazole (C₁₂H₁₅N₃O₂S) in the Tablet taken:

Result = (A_U /A_S) × (C_S /L) × V × D × 100

A_U = absorbance of Sample solution at about 308 nm − absorbance of Sample solution at about 350 nm  

A_S = absorbance of Standard solution at about 308 nm − absorbance of Standard solution at about 350 nm

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

L = label claim (mg/Tablet)

V = volume of the Sample solution, 500 mL

D = dilution factor of the Sample solution, 50

5 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight containers, and store at controlled room temperature.

Change to read:

Labeling: When more than one Dissolution test is given, the labeling states the Dissolution test used only if Test 1 is not used. (RB 3-Mar-2021) Tablets intended for veterinary use only are so labeled.

USP Reference Standards 〈11〉

USP Albendazole RS

USP Parbendazole RS