RP-HPLC method for quantitative estimation of naftifine hydrochloride in formulated products: development and validation

Kajal Sunil Shinde; Chandraprabhu Motichand Jangme; Abhinandan Raosaheb Patil

doi:10.69857/joapr.v13i4.1115

Authors

Kajal Sunil Shinde Dept. of Pharmaceutical Science, Centre for Interdisciplinary Research, D. Y. Patil Education Society (Deemed to be University), Kolhapur, 416006, Maharashtra, India
Chandraprabhu Motichand Jangme Department of Pharmacology, D. Y. Patil College of Pharmacy, D. Y. Patil Education Society, Deemed to Be University, Kolhapur 416006, Maharashtra, India
Abhinandan Raosaheb Patil Department of Pharmaceutics, D. Y. Patil College of Pharmacy, D. Y. Patil Education Society, Deemed to Be University, Kolhapur 416006, Maharashtra, India

DOI:

https://doi.org/10.69857/joapr.v13i4.1115

Keywords:

Naftifine hydrochloride, reversed-phase HPLC, validation, pharmaceutical, topical antifungal

Abstract

Background: Naftifine hydrochloride is an allylamine antifungal agent commonly used to treat dermatophyte infections. It inhibits squalene epoxidase, a key enzyme in ergosterol biosynthesis, thereby disrupting the integrity of the fungal cell membrane. It exhibits broad-spectrum activity against dermatophytes, yeasts, and molds, and is typically formulated as a 1% topical cream or gel. Methodology: A rapid and robust reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the estimation of naftifine hydrochloride in a topical cream formulation (2% Naftifast, Zydus), in accordance with ICH and FDA guidelines. Chromatographic separation was achieved on an Inertsil ODS column using an isocratic mobile phase consisting of 35% acetonitrile, 40% methanol, 25% water, and 0.8% triethylamine (pH adjusted to 5.5 with acetic acid) at a flow rate of 1.4 mL/min. Detection was performed at 265 nm. Results and Discussion: Naftifine hydrochloride showed a retention time of approximately 4.0 minutes with a total run time of 6.0 minutes. The method displayed excellent linearity over a concentration range of 20–120 µg/mL (R² > 0.999). Recovery studies indicated a mean recovery of 100.4%. Precision was confirmed by relative standard deviation (RSD) values of less than 2%, demonstrating the method’s reproducibility. Conclusion: The proposed RP-HPLC method is simple, precise, and time-efficient. It is suitable for routine quality control of naftifine hydrochloride in pharmaceutical dosage forms due to its short analysis time and strong validation performance.

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