Research Article - Journal of RNA and Genomics (2022) Volume 0, Issue 0

Development of novel analytical bioanalytical methods of Sorafenib tosylate and its degradation and stability studies by RP-UFLC method.

Sorafenib tosylate (ST) is a kinase inhibitor drug approved for the treatment of primary kidney cancer, advanced liver cancer and in radioactive iodine resistant thyroid carcinoma. The efficacy and toxicity of the drug is dose dependent manner. A rapid and sensitive method for analytical and bioanalytical determination of sorafenib tosylate was developed and validated according to ICH guidelines. The drug was also studied for degradation and stability properties under different conditions. The analysis was carried out by using UFLC AD 20 with UV detection. The chromatographic peak was achieved at 2.6 min on a reversed-phase column 18 at 40 ºC by applying a gradient elution method with a methanol and acetonitrile in the ratio of 90:10 were used at 1.00 ml/min and was detected at 265 nm. Calibration curve is linear in the concentration range of 5-25 μg/ml (r2=0.9929). The %RSD of intraday and interday was within 2% and accuracy percentage ranged from 98.24 to 99.91. The results of newly developed UFLC method are more sensitive precise and accurate than previous reported methods using UV detection. This new analytical method is applied successfully for bioanalytical method development. The method is efficiently improved bioavailability and evidenced by validation parameters. In degradation study, percentage of degradation observed was less in all the conditions. In stability study, the drug was found to more stable. The developed method can be used for routine analysis of sorafenib tosylate in pharmaceutical formulation and in human plasma.

Author(s): Shravani M, Jaishree Vaijanathappa*, Nagashree KS

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