Miconazole Nitrate Cream

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

Miconazole Nitrate Cream contains NLT 90.0% and NMT 110.0% of the labeled amount of miconazole nitrate (C₁₈H₁₄CI₄N₂O · HNO₃).

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

PROCEDURE

Buffer: Triethylamine and water (10:1000). Adjust with phosphoric acid to a pH of 2.5.

Mobile phase: Methanol, acetonitrile, tetrahydrofuran, and Buffer (5:4:3:8)

Standard solution: 0.28 mg/mL of USP Miconazole Nitrate RS and 0.02 mg/mL of benzoic acid in Mobile phase

Sample solution: Nominally 0.28 mg/mL of miconazole nitrate in Mobile phase prepared as follows. Dissolve a weighed quantity of Cream in Mobile phase, and sonicate in a water bath at 40°–45° until the sample is completely dispersed. Cool the solution to below room temperature, and pass through a 0.45-µm Teflon filter into an HPLC vial.

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 225 nm

Column: 4.6-mm x 25-cm; packing L11

Column temperature: 45°

Flow rate: 1 ml/min

Injection volume: 10 µL

System suitability

Sample: Standard solution

Suitability requirements

Resolution: NLT 13 between miconazole nitrate and benzoic acid

Column efficiency: NLT 7500 theoretical plates for the miconazole nitrate peak

Tailing factor: NMT 2.0 for the miconazole nitrate peak

Relative standard deviation: NMT 2.0% from the miconazole nitrate peak

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of miconazole nitrate (C₁₈H₁₄CI₄N₂O · HNO₃) in the portion of Cream 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 Miconazole Nitrate RS in the Standard solution (mg/mL)

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

Acceptance criteria: 90.0%-110.0%

4 PERFORMANCE TESTS

MINIMUM FILL (755): Meets the requirements

5 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Preserve in collapsible tubes or tight containers, and store at controlled room temperature.

LABELING: Cream that is packaged and labeled for use as a vaginal preparation shall be labeled Miconazole Nitrate Vaginal Cream.

USP REFERENCE STANDARDS (11)

USP Miconazole Nitrate RS