Abstract

FIRST DERIVATIVE UV-SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF FENTICONAZOLE NITRATE CREAM MATRIX

Josilene Chaves Ruela Corrêa*, Lígia Maria Comineli Beltrame and Hérida Regina Nunes Salgado

ABSTRACT

The fenticonazole nitrate is an imidazole derivative and has a broad spectrum antimycotic activity. It has been commonly used for treatment of dermatologic and gynecologic fungal infections, mainly for those caused by Candida albicans. Although the importance of the drug, there are limited analytical methods developed for assuring its quality in complex pharmaceutical forms. Therefore, the objective of this work was to develop and validate such a matrix interference free analytical method for the fenticonazole nitrate assay in vaginal cream formulation. This paper presents a new, simple, inexpensive, efficient and matrix interference free by using derivative tools of UV spectrophotometric technique for determination of fenticonazole nitrate in vaginal creams. The method was validated as established in the International Conference on Harmonization (ICH) requirements and has shown selectivity, linearity, accuracy, and precision, besides low detection and quantitation limits. This procedure does not require complex or expansive equipment neither complicated separation method and uses simple reagents. It is an important tool for routine quality control of fenticonazole nitrate and may be useful for pharmaceutical industry quality control analysis of drug in complex matrixes as vaginal creams.

Keywords: Derivative spectrophotometry, complex pharmaceutical matrix, quality control, fenticonazole nitrate.