Abstract

Itraconazole and Terbinafine are widely used antifungal agents with diverse applications in the pharmaceutical industry. The simultaneous estimation of these two drugs in bulk form and dosage formulations is essential for quality control and regulatory compliance. This review comprehensively evaluates various analytical methods reported in the literature for the simultaneous estimation of Itraconazole and Terbinafine. The review highlights the significance of method development in achieving accurate and precise quantification of these drugs. Different analytical techniques such as spectrophotometry, chromatography (high-performance liquid chromatography, ultra-performance liquid chromatography), and capillary electrophoresis have been explored for this purpose. Additionally, various sample preparation techniques including liquid-liquid extraction, solid-phase extraction, and derivatization have been employed to enhance sensitivity and selectivity. Additionally, recent advancements in analytical instrumentation and method optimization strategies are discussed, offering insights into the future direction of method development for simultaneous estimation of Itraconazole and Terbinafine. Overall, this review serves as a valuable resource for researchers and analysts involved in pharmaceutical analysis, providing guidance for the selection and optimization of suitable methods for the simultaneous determination of these important antifungal agents.

Keywords

Introduction

Itraconazole and Terbinafine are widely used antifungal agents with diverse applications in the pharmaceutical industry. The simultaneous estimation of these two drugs in bulk form and dosage formulations is essential for quality control and regulatory compliance. This review comprehensively evaluates various analytical methods reported in the literature for the simultaneous estimation of Itraconazole and Terbinafine. The review highlights the significance of method development in achieving accurate and precise quantification of these drugs. Different analytical techniques such as spectrophotometry, chromatography (high-performance liquid chromatography, ultra-performance liquid chromatography), and capillary electrophoresis have been explored for this purpose. Additionally, various sample preparation techniques including liquid-liquid extraction, solid-phase extraction, and derivatization have been employed to enhance sensitivity and selectivity. Additionally, recent advancements in analytical instrumentation and method optimization strategies are discussed, offering insights into the future direction of method development for simultaneous estimation of Itraconazole and Terbinafine. Overall, this review serves as a valuable resource for researchers and analysts involved in pharmaceutical analysis, providing guidance for the selection and optimization of suitable methods for the simultaneous determination of these important antifungal agents.

Figure 1. Chemical Structure of Itraconazole.

       
           
       
    Figure 2. Chemical Structure of Terbinafine.

DRUG PROFILE

Table 1: Drug Profile of Itraconazole and Terbinafine.

METHOD DEVELOPMENT AND LITERATURE STUDY IN BULK AND PHARMACEUTICAL DOSAGE FORM:

1. Reverse Phase High-Performance Liquid Chromatography:

Reverse Phase High-Performance Liquid Chromatography is a term that is commonly used to describe liquid chromatography, which consists of a liquid mobile phase that is mechanically pumped through a stationary phase-containing column. An HPLC system consists of an injector, a pump, a column, and a detector [19] . The pump is in charge of regulating the flow of solvent through the system. After leaving the pump, the solvent passes through the injector, then through the section, and then through the optical unit of a detector HPLC columns are made up of spherical silica gel beads coated with the hydrophobic stationary phase and packed into the column. C4 (butyl), C8 (octyl), C18 (octadecyl), phenyl (phenylpropyl), and nitrile (cyanopropyl) columns are common stationary phases [20-24]

Table 2 – Summary of RP- HPLC method for determination of Itraconazole and Terbinafine:

UV Spectrophotometric Method:

The primary idea behind UV spectroscopy states that the excitation of electrons in individual atoms and molecules from lower to higher energy levels is responsible for the absorption of visible and ultraviolet light, or light in the 200–400 nm range [27]. The concentration of the absorbing species in the solution and the path length are proportional to the absorbance of a solution, as per the Beer-Lambert law [28].

Principle: Absorption in the visible or ultraviolet range happens when radiation causes an electronic change within the structure of a molecule or particle. Consequently, the electronic state of the molecules within a sample changes when it absorbs light in the visible or ultraviolet spectrum. Electrons can be promoted from their ground state orbitals to higher orbitals by energy[29].

Table 3 – Summary of UV Spectrophotometric method for Itraconazole and Terbinafine:

Stability-Indicating Method Development And Validation :

The stability-indicating assay is a verified quantitative technique that aids in the examination of sample stability in the pharmaceutical industry and can identify changes over time by examining the characteristics of drug ingredients and medicinal products. As to the ICH, the aim of a stability-indicating assay method is to precisely measure the intact drug or medications along with any additional components or excipients and breakdown products. To ensure that there is no peak overlap between the excipients, degradants, and the active medication, it is ideal for every component in the formulation to be present [30,31-33].

Table 4– Summary of stability Indicating method for Itraconazole and Terbinafine:

CONCLUSION:

The USFDA approved Itraconazole and Terbinafine in 1992.As a result of the above information, it can be concluded that the numerous analytical procedures used to determine simultaneous estimation of Itraconazole and Terbinafine alone or in combination have been successfully utilized on a routine basis, allowing the drug to be quantified in various pharmaceutical dosage forms. These procedures are all simple, fast, accurate, sensitive, and reproducible, with high linearity and precision.

ACKNOWLEDGMENT:

I would like to express my sincere thanks to Mrs.Hemlata Bhawar Mam and Dr. Santosh Dighe for their valuable guidance and support for this review work.

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