Abstract
Objective: This investigation demonstrates a stability-indicating and reliable “normal phase ultra-performance liquid chromatography” method to simultaneously quantify Ramucirumab and Erlotinib in the pharmaceutical dosage form. Methods: Successful separation was accomplished using Chiralcel-OD-3 column (50 mm x 4.6 mm, 3 μm) with an isocratic type of elution using a mobile phase containing n-hexane+isopropyl alcohol+methanol (89:10:1), respectively with 1.0 ml/min flow rate. The wavelength sensor was attuned at 266 nm to quantify Ramucirumab and Erlotinib. Results: Erlotinib and Ramucirumab peaks were eluted with fine resolution at retention times 1.7807 min and 3.175 min, respectively. In the 10-150 μg/ml and 1-15 μg/ml concentration ranges for Erlotinib and Ramucirumab, the calibration graphs were linear, with regression coefficients of 0.99928 and 0.99976, respectively. The suggested ultra-performance liquid chromatography approach has been shown as sensitive, precise, robust, accurate, specific and stability indicating through the resolution of Erlotinib and Ramucirumab from its degradation-based compounds. Conclusion: The established ultra-performance liquid chromatography technique was effectively extended to the evaluation of Erlotinib and Ramucirumab in the pharmaceutical dosage form and the test results appeared satisfactory.
Highlights
Ramucirumab trade name Cyramza is a fully human monoclonal antibody [1, 2] (IgG1) developed for the treatment of solid tumors [3]. the US Food and Drug Administration (FDA) approved ramucirumab as a single-agent treatment for advanced gastric cancer [4, 5] or gastroesophageal junction [6](GEJ) adenocarcinoma [7] after prior treatment with fluoropyrimidine-or platinum-containing chemotherapy [8, 9]
The approval was based on the results of the REGARD trial, a phase III, international, randomized, double-blind, placebocontrolled study that evaluated the safety and efficacy of ramucirumab combinated with best supportive care versus placebo [10]
Binding of ramucirumab to VEGFR2 leads to inhibition of VEGFmediated tumor angiogenesis
Summary
Ramucirumab trade name Cyramza is a fully human monoclonal antibody [1, 2] (IgG1) developed for the treatment of solid tumors [3]. the US Food and Drug Administration (FDA) approved ramucirumab as a single-agent treatment for advanced gastric cancer [4, 5] or gastroesophageal junction [6](GEJ) adenocarcinoma [7] after prior treatment with fluoropyrimidine-or platinum-containing chemotherapy [8, 9]. The approval was based on the results of the REGARD trial, a phase III, international, randomized, double-blind, placebocontrolled study that evaluated the safety and efficacy of ramucirumab combinated with best supportive care versus placebo [10]. This trial has been criticised for its use of a placebo control arm, which does not reflect standard of care in most. These ligands are secreted by solid tumors to promote angiogenesis [12, 13] (formation of new blood vessels from pre-existing ones) and enhance tumor blood supply.
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