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
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- EP ID EP33155
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