Naftifine Hydrochloride Cream
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
1 DEFINITION
Naftifine Hydrochloride Cream contains NLT 90.0% and NMT 110.0% of the labeled amount of naftifine hydrochloride (C₂₁H₂₁N · HCl) in a water-miscible base.
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: n-Hexane, alcohol, dimethylformamide, and formic acid (200:60:40:2). Cover tightly with a moisture-proof film, and allow to stand for 12 h at room temperature.
Standard solution: 0.2 mg/mL of USP Naftifine Hydrochloride RS in Mobile phase
Sample solution: Transfer 1000 mg of Cream to a 100-mL volumetric flask. Dissolve in 60 mL of methanol, mix vigorously for 2 min, and dilute with methanol to volume. Heat at 45° for 5 min, and cool to room temperature.
Chromatographic system
- (See Chromatography 〈621〉, System Suitability.)
- Mode: LC
- Detector: UV 270 nm
- Column: 4.6-mm × 25-cm; 5-µm packing L3
- Flow rate: 2 mL/min
- Injection volume: 15 µL
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of the labeled amount of naftifine hydrochloride (C₂₁H₂₁N · HCl) in the portion of Cream 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 Naftifine Hydrochloride RS in the Standard solution (mg/mL)
Cᵤ = nominal concentration of naftifine hydrochloride in the Sample solution (mg/mL)
Acceptance criteria: 90.0%–110.0%
4 PERFORMANCE TESTS
Minimum Fill 〈755〉: Meets the requirements
5 SPECIFIC TESTS
Microbial Enumeration Tests 〈61〉 and Tests for Specified Organisms 〈62〉: It meets the requirements of the tests for absence of Staphylococcus aureus and Pseudomonas aeruginosa.
pH 〈791〉: 4.0–6.0
6 ADDITIONAL REQUIREMENTS
Packaging and Storage: Preserve in well-closed containers.
USP Reference Standards 〈11〉
USP Naftifine Hydrochloride RS
