A new development and validated RP-HPLC method for the assay and related substances of Itraconazole in capsule dosage form
Journal Title: Indian Journal of Research in Pharmacy and Biotechnology - Year 2013, Vol 1, Issue 6
Abstract
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 Χ 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 forced degradation and stability studies. The drug was found to be stable for 4 days in Assay and for 3 days in Related compounds determination. This method was appropriate for the purpose of quantitating Itraconazole in Drug Product and the Related Substances of Itraconazole in the Finished Product and has been successfully validated.
Authors and Affiliations
Sarvani Paruchuri, Haritha Pavani K
Keywords
Related Articles
- EP ID EP33155
- DOI -
- Views 317
- Downloads 0
Formulation, characterization and evaluation of zidovudine controlled release matrix tablets using HPMC K4M and K100M
The aim of present investigation is preparation, characterization and evaluation of oral controlled release matrix tablets of Zidovudine (AZT) in order to improve efficacy and reduce its side effects. FTIR and DSC conf...
Evaluation of methanolic extract of Celtis timorensis for nootropic activity
The present study was undertaken to investigate the nootropic activity of leaves of methanolic extract of Celtis Timorensis. Three doses of extracts 100, 200 and 400 mg/kg and piracetam (50 mg/kg, i.p.) were administer...
Anti-ulcer activity of aqueous extract of Sesbania grandiflora Linn stems in experimental animals
To evaluate gastric anti-ulcer potency of aqueous extract of Sesbania grandiflora Linn (Fabaceae) stems in experimental animals. The extract was investigated in ethanol induced ulcer models in Wister rats. In this mode...
Phytochemical, physicochemical and pharmacological profile of the selected plant Curcuma longa linn
In ethno medicinal practices, the traditional healers use the genus Curcuma for the treatment of various ailments Turmeric is a spice derived from the rhizomes of Curcuma longa, which is a member of the ginger family (...
ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF OLMESARTAN MEDOXOMIL BY RP-UPLC IN BULK AND PHARMACEUTICAL DOSAGE FORMS
A simple rapid, accurate, precise and reproducible validated reverse phase UPLC method was developed for the determination of Olmesartan medoxomil in bulk and pharmaceutical dosage forms. The quantification was carried...