Development and validation of a specific method for the detection and quantification of Bortezomib in the prepared Bortezomib bovine serum albumin nanoparticles

Abstract

New, simple and precise analytical method for the detection of Bortezomib which it is a selecti proteosome inhibitor acting as powerful anticancer drug. This method is developed and validated using reverse phase High performance liquid chromatography (HPLC) device with( C18,4.6×250mm )column, mobile phase composed of methanol: water (70:30) , isocratic flow rate of 1 ml/min and UV detection at 270 nm. The retention time for this drug is found to be 6.77 minute by utilizing this method. It is also proved to be precise and specific with an RSD% less than 2% which complies with the requirement of ICH. It also shows a linearity in the both responses (area and height) in the range of 10-100 µg/ml with a R2 0.997 and 0.998 respectively, indicating a wide range for the Bortezomib measurement in different pharmaceutical formulations. LOD and LOQ were also calculated to be 3.2 and 9.6 µg/ml respectively, showing a low level for detection and quantification of the item. The accuracy also is determined to be 99.83%±0.77. In conclusion the suggested method is validated according to ICH guidelines regarding precision, specificity, linearity, accuracy and robustness.