Stability-indicating high-performance thin-layer chromatographic method for analysis of itraconazole in bulk drug and in pharmaceutical dosage form

Abstract

Background:A new, simple, selective, precise, and stability-indicating high-performance thin-layer chromatographic method has been established for analysis of itraconazole (ITZ) in the bulk drug and in pharmaceutical formulations. Separation was achieved on aluminium plate precoated with silica gel 60F254 using Toluene : Chloroform : Methanol [5 : 5 : 1.5 (v/v)] as mobile phase. Densitometric analysis was performed at 260 nm.Result:Compact bands of ITZ were obtained at Rf 0.52 ± 0.02. Linearity (R2 = 0.9978), limit of detection (180.29 ng/band), limit of quantification (546.34 ng/band), recovery (98–102%), and precision (≤0.51%) were satisfactory. Drug was not degraded under neutral and alkaline hydrolysis, UV and photolytic degradation, under-elevated temperature, and humidity. ITZ is degraded under acidic hydrolysis and oxidative condition; the degraded products were well resolved from individual bulk drug response. Developed method can effectively resolve drug from its excipients in capsule dosage form. The specificity of the method was confirmed by peak purity of resolved peak.Conclusion:The method can be applicable for routine analysis of ITZ in pharmaceutical formulation as stability-indicating. Because the method can effectively separate the drug from its degradation products as well as excipients, it can be used as a stability-indicating method.

Determination of itraconazole and its photodegradation products with kinetic evaluation by ultra‐performance liquid chromatography/tandem mass spectrometry

“…Parikh et al . () performed forced degradation studies of ITZ in a capsule dosage form using high‐performance thin‐layer chromatographic method. Dettlaff et al .…”

“…The drug turned out to be unstable under UV-B irradiation, suffering a primary dehalogenation of the 2,4-dichlorophenyl moiety that occurs mainly at the ortho-position (Nardi et al, 2014). Parikh et al (2011) performed forced degradation studies of ITZ in a capsule dosage form using highperformance thin-layer chromatographic method. Dettlaff et al (2015) investigated the ionizing radiation effects, in a form of an electron beam, on ITZ in solid phase and the structures of all impurities and radiolysis products were proposed.…”

Stability Indicating RP-HPLC Method For Determination Of Itraconazole In Bulk Drug And In Capsule Dosage Form

“…[11] Apart from this, UV sepctrophotometric and HPTLC methods are available for determination of ITZ in bulk drug and dosage forms. [12,13,14] Chromatographic separation in this method was performed on an octadecylsilane column using fluorescence detector. [8] Consequently, the implementation of a simple, effective and reproducible analytic methodology to determine ITZ in pharmaceutical dosage form is a pending challenge of the pharmaceutical analysis.…”

Development and Validation of Reverse‐Phase High‐Performance Liquid Chromatography Method for Estimation of Itraconazole through Hydroxypropyl Methylcellulose Acetate Succinate based Polymeric Films using Quality by Design principles

“…Many literature references have described the separation and quantification of itraconazole, its degradation products, and impurities in bulk drug or solid oral dosage forms [7]. There are various analytical methods for estimation of itraconazole through UV [8–14], reverse‐phase HPLC [15–23], and TLC methods [24]. Kumudhavalli reported an isocratic reverse‐phase UV method with mobile phase containing tetrabutylammonium hydrogen sulfate buffer solution and acetonitrile (40:60) ratio and flow rate of 1.5 mL/min to elute itraconazole with retention time 5.6 min [15].…”