Background
Using a Symmetry C18 (4.6 × 150 mm, 3.5) column, a high-performance liquid chromatographic method for quantification of Rilpivirine and Cabotegravir in active pharmaceutical ingredients was developed and validated. The mobile phase is made up of buffer, acetonitrile, and 0.1 percent formic acid in a 20:80v/v ratio. The flow rate was kept constant at 1.0 ml/min, and detection was accomplished through absorption at 231 nm with a photodiode array detector.
Results
The calibration curve was linear, with a regression coefficient (R2) value of 0.999 and concentrations ranging from 30 to 450 g/ml of Rilpivirine and 20–300 g/ml of Cabotegravir. The method's LOD and LOQ were 0.375 g/ml, 1.238 g/ml, and 0.25 g/ml, 0.825 g/ml for Rilpivirine and Cabotegravir, respectively.
Conclusions
In the forced degradation studies, the degradants were characterized by using LCMS and FTIR. The current application was found to be simple, economical, and suitable, and validated according to ICH guidelines.
Background:
Lenvatinib is a potent drug utilized in the medication of thyroid cancer
and it acts as a tyrosine kinase inhibitor. Thus, the development and validation of Lenvatinib and
allied impurities in rat plasma, and its pharmacokinetic study, are one of the most significant areas
of modern pharmaceutical analysis.
Objective:
The current study conducts bioanalytical system validation and pharmacokinetic analysis
of Lenvatinib and associated impurities in rat plasma with LC-MS/MS.
Methods:
The current study involves bioanalytical system validation and pharmacokinetic analysis
of Lenvatinib and associated impurities in rat plasma using LC-MS/MS. Gradient elution of
Lenvatinib with a flow rate of 1 mL/min and an X-Bridge phenyl column (150x4.6 mm, 3.5μ)
was used in the optimized process. In this method, buffer (1 mL formic acid in 1 liter of water)
and acetonitrile mixture was used as the mobile phase.
Results:
By using Carfilzomib as the internal norm and impurity-4 as the active metabolite and
30 minute run time, Lenvatinib and its associated impurities were separated. The linearity was in
the range of 10 percent to 200 percent of rat plasma, and each analyte R2 value was found to be
0.999.
Conclusion:
This work indicates that all parameters, such as precision, recovery, accuracy, and
stability, were achieved as per USFDA guidelines. This approach can be used to investigate Lenvatinib
impurities and conduct pharmacokinetic studies involving rat plasma.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.