Yaswanth Allamneni

Forced degradation study is an important tool to identify the degradation of the drug substance1 when subjected to different stress conditions which is more useful than the accelerated stability testing during the formulation development. A simple and stability indicating HPLC method was developed for the characterization of assay and related substances of the drug substance. In the present investigation, bortezomib was subjected to different stress conditions like acid hydrolysis, base hydrolysis, oxidation, effect of heat and effect of light. Significant degradation was observed when Bortezomib sample solutions are exposed to acidic conditions and basic at room temperature. Drastic degradation was observed when bortezomib sample solutions are exposed to oxidation. Significant degradation was observed when bortezomib sample solution is exposed to heat at 60°C and exposed UV radiation. Solid state degradation data indicates that bortezomib has insignificant degradation upon exposure to UV light. The proposed analytical methods enable accurate, precise, and rapid analysis of Bortezomib. Stress study results helps in opting the solvents for the compounding process with respect to stability of the compound. Based on the stress study data, the product can be lyophilized in clear glass vial for the future prospective of novel lyophilized formulation.

  An isocratic reverse phase liquid chromatography (RP-HPLC) method has been developed and subsequently validated for the determination of Dasatinib in Bulk and its pharmaceutical formulation. Separation was achieved with a Cosmicsil BDS C18 ((Make: Nomura chemicals (Japan); 150 x 4.6mm I.D; particle size 5 μm)) Column and Triethlyamine buffer (pH adjusted to 6.5 ± 0.05 with diluted orthophosphoric acid): Maethanol and Acetonitrile (50:50) v/v as eluent at flow rate 1.0 mL/min and the Column temperature was 35°C. UV detection was performed at 315 nm and sample temperature was maintained at 5°C. The method is simple, rapid, and selective. The described method of Dasatinib is linear over a range of 3.821 μg/mL to 57.314 μg/mL. The method precision for the determination of assay was below 2.0% RSD. The percentage recoveries of active pharmaceutical ingredient (API) from dosage forms ranged from 98.5 to 99.8 %. The method enables accurate, precise, and rapid analysis of Dasatinib. It can be conveniently adopted for routine quality control analysis of Bulk and pharmaceutical formulations.