A Novel Gradient RP-HPLC Method Development for Bortezomib in Parenteral Dosage Form

The objective of present study was the development of gradient RP-HPLC method for the estimation of bortezomib in parenteral dosage form. The analysis was performed on Hypersil C 18 column (250 x 4.6mm) with mobile phase composed of acetonitrile: water: THF (65:35:5), maintaining flow rate at 1ml/min. with retention time of 3.5±0.5min. The detection was done at 280nm. A regression coefficient was 0.999 obeying the Beer’s law at concentration range of 20 – 120 µg/ml. The proposed method was validated for specificity, linearity, accuracy, precision and robustness as per ICH guidelines and used successfully for bortezomib determination in routinely quality control. KEY WORDS: Validation, RP-HPLC, Bortezomib.