Universal Journal of Pharmacy ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ITRACONAZOLE BY INSTRUMENTAL METHODS IN BULK DRUG AND MARKETED FORMULATION (original) (raw)
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2018
A new simple, accurate, rapid, selective and robust high pressure liquid chromatography (HPLC) method was developed and validated for estimation of itraconazole in bulk and marketed formulation. Acetonitrile and double distilled water was used as a mobile phase for chromatographic separation and estimation on HiQSil C18HS (250 × 4.6 mm) in the ratio of 90:10 v/v at flow rate of 1.0 ml/min. The detection was carried out with UV detector set at 263 nm. The retention time for itraconazole was found to be 7.75 minutes. The linearity range for itraconazole was found to be 5-60 μg/ml with coefficient of linear regression 0.991. The method was validated in accordance with the requirements of International Conference on Harmonization (ICHQ2 (R1) 2005) guidelines for accuracy, precision, LOD & LOQ, linearity and robustness.
2013
The present investigation reveals about a simple, economic, selective, precise and accurate reverse phase high performance liquid chromatography method for analysis of Itraconazole and Related Substances of Itraconazole was developed and validated according to ICH guidelines. Itraconazole was well separated using ThermoHypersil BDS C18, 150mm X 4.6 mm, 5µm column for assay quantification in isocratic mode with mobile phase comprising of buffer: Acetonitrile (65:35) with a flow rate of 1.5ml/min and ThermoHypersil BDS C18, 100 mm x 4.6 mm, 3 µm column for Related substances quantification in gradient mode with mobile phase comprising of 0.08M tetra butyl ammonium hydrogen sulphate: Acetonitrile with a flow rate of 1.5ml/min. the retention time was found to be 6.2min and % assay was found to be 99.9%. The percentage recovery was found to be 99.6 to 101.2%. Proposed method was validated for precision, accuracy, linearity, range, specificity and robustness. The drug was subjected to for...
2017
Itraconazole is a synthetic triazole antifungal agent. Itraconazole is formulated into several pharmaceutical forms available into market. Itraconazole capsules are used to treat fungal infection in the lungs that can spread throughout the body. Itraconazole is partially water soluble therefore methods available for assay of Itraconazole in pharmaceutical formulation use organic solvents thus available methods are not cost effective and difficult to routine use. In present work attempt has made to develop a more precise, simple and economical spectrophotometric method with combination of water and methanol as solvent with greater precision, accuracy and suitability for the quantitation of Itraconazole in capsule dosage form. UV spectroscopic determination was carried out at absorption maxima of 254 nm using Methanol: Water (40:60 % v/v) as solvent. In present UV spectroscopic method linearity over the concentration range of Itraconazole was found to be in between 50-150 µg/ml with a...
Review on Analytical Methods for Estimation of Itraconazole in Bulk and Pharmaceutical Dosage Form
https://www.ijrrjournal.com/IJRR\_Vol.8\_Issue.5\_May2021/IJRR-Abstract06.html, 2021
Itraconazole is an orally administered, trizole antifungal agent used in the treatment of systemic and superficial fungal infections. This includes infection in any part of body including the lungs, mouth or throat, toenails or fingernails. Some brands of itraconazole are not for use in treating fungal infections of the fingernails or toenails. Itraconazole has antimycotic properties. Formulated for both topical and systemic use.The objective of this review is to present summary and compilation of various research papers, which were already published in different national and international literature platform for estimation of itraconazole in bulk and pharmaceutical formulations with special emphasis on UV spectrophotometric and high performance liquid chromatography (HPLC) methods. There are various parameters used with UV Spectrophotometric and HPLC method, but few significant parameters are λmax, solvent for UV Spectrometric method and stationary phase, mobile phase, retention time, column in case of HPLC. This compilation review presents all the analytical methods which were already used for estimation of itraconazole with their important parameters, which will be beneficial for the researchers and add to the existing literature in this field.
Spectrofluorimetric Determination of Itraconazole in Dosage Forms and Spiked Human Plasma
Journal of The Chinese Chemical Society, 2007
A highly sensitive fluorimetric method was developed for the determination of itraconazole in pharmaceutical preparations and biological fluids. The proposed method is based on measuring the native fluorescence intensity of itraconazole in methanol at 380 nm after excitation at 260 nm. The fluorescence intensity-concentration plot was rectilinear over the range 0.2 to 2.0 mg/mL with a lower detection limit of 0.05 mg/mL (6.52´10-11 M). The method was further applied to the determination of itraconazole in capsules and spiked human plasma, the mean % recoveries (n = 4) was 100.37 ± 0.86 and 95.47 ± 2.93, respectively. The mean % recoveries were in agreement with those obtained from a reference method.
Die Pharmazie, 2009
A rapid and highly sensitive liquid chromatography/electrospray ionization tandem mass spectrometric method (LC/ESI-MS/MS) for itraconazole determination in human plasma was validated and applied to pharmacokinetic and bioequivalence study in humans. In a randomized crossover design with a 1-week period, each subject received a 200 mg itraconazole capsule. The analytical procedures involved a less time-consuming, simple protein precipitation with methyl t-butyl ether and separation by HPLC. The ionization was optimized using electrospray ionization (ESI) with positive ion mode and selectivity was achieved by MS/MS analysis, m/z 705.3 --> 392.4 and m/z 374.3 --> 141.0 for itraconazole and internal standard (IS), respectively. The standard calibration curves showed good linearity within the range of 1 (LLOQ) to 500 ng/mL for itraconazole in human plasma with a correlation coefficient r > 0.9952. The retention times of itraconazole (0.9 min) and IS (0.84 min) suggest the high ...
Selection of the most appropriate experimental conditions for a particular analysis can be a very tedious and time consuming process. Researchers are abandoning the old--fashioned, classical approach one-factor-at-a-time and substituting it with modern, ad-159 Acta Pharm. 63 (2013) 159-173 This paper presents the chemometrically assisted optimization and validation of the RP-HPLC method intended for the quantitative analysis of itraconazole and its impurities in pharmaceutical dosage forms. To reach the desired chromatographic resolution with a limited number of experiments in a minimum amount of time, Box--Behnken design was used to simultaneously optimize some important chromatographic parameters, such as the acetonitrile content in the mobile phase, pH of the aqueous phase and the column temperature. Separation between itraconazole and impurity F was identified as critical and selected as a response during the optimization. The set optimal mobile phase composition was acetonitrile/water pH 2.5 adjusted with o-phosphoric acid (50:50, V/V). Separations were performed on a Zorbax Eclipse XDB-C18, 4.6´150 mm, 5 mm particle size column with the flow rate 1 mL min -1 , column temperature set at 30°C and UV detection at 256 nm. The established method was then subjected to method validation and the required validation parameters were tested. For the robustness evaluation, fractional factorial 2 4-1 design was utilized and factors that might significantly affect the system performance were defined. As other validation parameters were also found to be suitable, the possibility to apply the proposed method for the determination of itraconazole, its impurities B and F in any laboratory under different circumstances has been proven.