Bortezomib is indicated for single-agent use in the treatment of patients with multiple myeloma who have received at least two prior therapies and are progressing on their most recent therapy. Clinical investigations are underway to evaluate the safety and efficacy of Bortezomib alone or in combination with chemotherapy in multiple Myeloma, both at relapse and presentation, as well as in other cancer types. A Novel, rapid, precise, economical, and Accurate HPLC method for estimation of Bortezomib in bulk and formulations was developed and validated. Quantitative HPLC was performed on a binary gradient HPLC with Shimadzu LC20AT and LC20AT VP series HPLC pumps, with a 20μl injection of sample loop (manual), and SPD20 A VP UV–visible Detector. The Chromatographic resolution of Bortezomib was achieved using Acetonitrile: 0.1M Ammonium phosphate (acetic acid) Buffer, (60:40 V/V) as a mobile phase, UV detection at 230 nm, and BDS Hypersil C8 column flow rate 1ml/min. the extraction Recovery of Bortezomib from its formulation dosage form (tablets) was >99.59%, and the calibration curve was linear (r2 = 0.999) over Bortezomib concentration ranging from 20 to 120 μg/ml. the method has an accuracy of > 99% and LOD and LOQ of 0.51900 μg /ml and 2.43450 μg/ml, respectively. A result of the present method was validated statistically and by recovery studies, which were found to be satisfactory. This linearity range covers all the strengths of Bortezomib, hence this can be conveniently used in the pharmaceutical manufacturing and formulation environment.
Author
(s) Details
Sirugubattula
Poojitha
Department of Medicine, Mediciti Institute of Medical Sciences,
Ghanpur, Medchel, Telangana, India.
Sirugubattula
Venkat Rao
Department of Chemistry, Dr Sven Laboratories Pvt Ltd., Hyderabad,
Telangana, India.
Meka
Ganesh
Department of Chemistry, Dr Sven Laboratories Pvt Ltd., Hyderabad,
Telangana, India.
Please see the book here:- https://doi.org/10.9734/bpi/psnid/v5/3767
