Evaluation of the Possibility of Using the Method of UV Spectrophotometry for the Development of Quantitative Determination of Naftifine Hydrochloride in its Solution with a Combination of PEG for the Treatment of Fungal Infections

• Main Authors: S. I. Kosenkova, I. I. Krasnyuk, I. I. Krasnyuk (jr.), A. V. Belyatskaya, O. I. Stepanova, S. R. Naryshkin
• Format: Article
• Language: Russian
• Published: LLC Center of Pharmaceutical Analytics (LLC «CPHA») 2020-02-01
• Series: Разработка и регистрация лекарственных средств
• Subjects: quantitation; naftifine hydrochloride; polyethylenglycol (peg); uv spectrophotometry; optical density
• Online Access: https://www.pharmjournal.ru/jour/article/view/745
• ISSN: 2305-2066; 2658-5049

Introduction. An innovative antifungal agent based on hydrochloride with combination of PEG-400 and PEG-1000 has been developed based at the chairs of Sechenov University. This solution is designated for external application as an antifungal agent. Naftifine hydrochloride has a broad spectrum of action against various fungi capable of causing onychomycosis. PEGs, forming part of the developed dosage form, bring about necessary viscosity of the solution (for retention in application area) and do not prevent drug product performance. Naftifine hydrochloride has an apparent UV absorption band with maximum of 256 ± 2 mn, in connection with this, it is supposed to use the UV spectrophotometry method for further development of quantitation method of naftifine hydrochloride detection in tested oral liquid.Aim. To evaluate the feasibility of using the UV spectrophotometry method for development of quantitation of naftifine hydrochloride in its solution with a combination of PEG for mycotic infection treatment.Materials and methods. The substance of naftifine hydrochloride, PEG-400 and PEG-1000, ethyl alcohol 96 %, UV spectrophotometry, «Millipore» filter.Results and discussion. A set of operations was carried out with UV spectrophotometer, including trials of solutions of initial substance of naftifine hydrochloride, PEG solutions, a solution of developed prolonged antimycotic drug and its placebo. The identity of UV spectra of the actual substance in various media was determined, maximum absorption of actual substance and dependence preservation between specified concentration and optical density of the solution were proved. It was found that auxiliary substances included in liquid dosage form do not affect the main characteristics of the UV spectrum of actual substance.Conclusion. The possibility in principle of using the UV spectrophotometry method for quantitative and qualitative analysis of innovative prolonged antimycotic drug – liquid dosage form of naftifine hydrochloride with a combination of PEG has been established.