Volume 9, Issue 1, January 2019
A New Simple Method Development and Validation of Ibrutinib In Bulk and Pharmaceutical Dosage Form By RP-HPLC
Author(s): Santhosh illendula*, Dhandempally Priyanka, V. Shirisha
Abstract: A simple, rapid, precise, accurate and sensitive reverse phase liquid chromatographic method has been developed for the determination of Ibrutinibin bulk and pharmaceutical dosage form. The chromatographic method was standardized using Develosil ODS HG-5 RP C18, 5μm, 15cmx4.6mm i.d. column with UV detection at 287nm and mobile phase with the composition of 0.1% Orthophosphoric Acid: Methanol with 35:65 ratio at a flow rate of 1.0 ml/ mi. The proposed method was successfully applied to the determination of Ibrutinib in bulk and pharmaceutical dosage form. The method was linear over the range of 0-14μg/ml. The recovery was in the range of 98% to 102% and limit of detection was found to be 0.09 μg/ml and quantification was found to be 0.29 μg/ml. Different analytical performance parameters such as precision, accuracy, limit of detection, limit of quantification and robustness were determined according to International Conference on Harmonization (ICH) guidelines.
PAGES: 36-46 | 985 VIEWS 95 DOWNLOADS
How To Cite this Article:
Santhosh illendula*, Dhandempally Priyanka, V. Shirisha. A New Simple Method Development and Validation of Ibrutinib In Bulk and Pharmaceutical Dosage Form By RP-HPLC. 2019; 9(1): 36-46.