Griseofulvin 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

Griseofulvin Tablets contain NLT 90.0% and NMT 115.0% of the labeled amount of griseofulvin (C₁₇H₁₇ClO₆).

2 IDENTIFICATION

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

3 ASSAY

3.1 Procedure

Mobile phase: Acetonitrile, tetrahydrofuran, and water (35:5:60). Degas for 5 min before use, and stir continuously during use.

Standard stock solution: 1.25 mg/mL of USP Griseofulvin RS in methanol

Standard solution: 0.125 mg/mL of USP Griseofulvin RS in Mobile phase from the Standard stock solution

Sample stock solution: Nominally 1.25 mg/mL of griseofulvin in methanol prepared as follows. Transfer the required number of finely powdered Tablets, based on the labeled amount, to a suitable volumetric flask and shake for at least 30 min in methanol. Dilute with methanol to volume, mix, and pass through a suitable filter.

Sample solution: 0.125 mg/mL of griseofulvin in Mobile phase from the Sample stock solution

3.2 Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 254 nm

Column: 4.6-mm × 25-cm; packing L10

Flow rate: 1 mL/min

Injection volume: 20 μL

3.3 System suitability

Sample: Standard solution

3.4 Suitability requirements

Relative standard deviation: NMT 2.0%

3.5 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of griseofulvin (C₁₇H₁₇ClO₆) in the portion of Tablets taken:

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

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution

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

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

P = potency of griseofulvin in USP Griseofulvin RS (μg/mg)

Acceptance criteria: 90.0%–115.0%

4 PERFORMANCE TESTS

Dissolution

4.1 Test 1

Medium: Water containing 40.0 mg/mL of sodium lauryl sulfate; 1000 mL

Apparatus 2: 75 rpm

Time: 90 min

Diluent: Methanol and water (40:10)

Sample solution: Sample per Dissolution 〈711〉. Dilute with Diluent, if necessary.

Standard solution: USP Griseofulvin RS at a known concentration similar to that of the Sample solution, prepared in the same Medium

Analysis: Determine the percentage of the labeled amount of griseofulvin (C₁₇H₁₇ClO₆) dissolved using UV absorption at the wavelength of maximum absorbance at about 291 nm.

Tolerances: NLT 75% (Q) of the labeled amount of griseofulvin (C₁₇H₁₇ClO₆) is dissolved.

4.2 Test 2

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

Medium: 4% sodium lauryl sulfate in water; 1000 mL

Apparatus 2: 50 rpm

Time: 45 min

Diluent: Methanol and water (40:10)

Standard solution: 10 μg/mL of USP Griseofulvin RS in Diluent

Sample solution: Pass a portion of the solution under test through a suitable filter. Dilute with Diluent, if necessary, to obtain a concentration similar to that of the Standard solution.

4.2.1 Instrumental conditions

Mode: UV

Analytical wavelength: 291 nm

4.2.2 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of griseofulvin (C₁₇H₁₇ClO₆) dissolved:

Result = (A_U/A_S) × C_S × V × D × (1/L) × 100

A_U = absorbance of the Sample solution

A_S = absorbance of the Standard solution

C_S = concentration of USP Griseofulvin RS in the Standard solution (μg/mL)

V = volume of the Medium, 1000 mL

D = dilution factor of the Sample solution

L = label claim (mg/Tablet)

Tolerances: NLT 80% (Q) of the labeled amount of griseofulvin (C₁₇H₁₇ClO₆) is dissolved.

Change to read:

Uniformity of Dosage Units 〈905〉: Meet the requirements (CN 1-Aug-2023)

Procedure for content uniformity

Standard solution: 10 μg/mL of USP Griseofulvin RS in methanol

Sample solution: Transfer 1 Tablet to a suitable container; add a measured volume of methanol sufficient to yield a concentration of griseofulvin NMT 1 mg/mL; shake by mechanical means for 1 h, or longer if necessary, to disperse the specimen completely; and sonicate for 1 min. Centrifuge a portion of this solution, and quantitatively dilute a volume of the clear supernatant to obtain a Sample solution containing about 10 μg/mL of griseofulvin.

Blank: Methanol

Instrumental conditions

Mode: UV

Analytical wavelength: 292 nm

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of griseofulvin (C₁₇H₁₇ClO₆) in the portion of Tablets taken:

Result = (A_U/A_S) × (C_S/C_U) × P × 100

A_U = absorbance of the Sample solution

A_S = absorbance of the Standard solution

C_S = concentration of USP Griseofulvin RS in the Standard solution (μg/mL)

C_U = nominal concentration of the Sample solution (μg/mL)

P = potency of griseofulvin in USP Griseofulvin RS (μg/mL) (CN 1-Aug-2023)

5 SPECIFIC TESTS

Loss on Drying 〈731〉

Analysis: Dry the sample at 60° for 3 h in a capillary-stoppered bottle under vacuum.

Acceptance criteria: NMT 5.0%

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight containers.

Labeling: The label indicates that the griseofulvin contained is known as griseofulvin (microsize). When more than one Dissolution test is given, the labeling states the Dissolution test used only if Test 1 is not used.

USP Reference Standards 〈11〉

USP Griseofulvin RS