PERAMIVIR AND RELATED IMPURITIES IN RAT PLASMA AND ITS APPLICATIONS IN PHARMACOKINETIC STUDIES (BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION BY LC-MS/MS)
Keywords:Peramivir, LC-MS/MS, Development, Validation, Rat plasma
Objective: New LC-MS/MS method for the estimation of Peramivir and its associated substances was developed and validated
Methods: Optimized (Developed) method includes gradient elution of peramivir and its related substances with a flow of 1 ml/min and waters X-bridge C18 column of dimensions 150 mmx4.6 mm, 3.5µ. 0.1% formic acid and acetonitrile were used as the mobile phase. Sarilumab was used as an internal standard. 40 min run time was used to separate peramivir and its related substances.
Results: The calibration curve was linear in the concentration percentage range from 10%-200% of Peramivir and its related substances. The calibration charts plotted were linear with a regression coefficient of R2>0.999. Accuracy, precision, recovery, matrix effect and stability results were found to be within the suitable limits. A Simple and efficient method was developed and utilized in pharmacokinetic studies to see the investigated analyte in body fluids.
Conclusion: This application denotes all parameters such as accuracy, precision, recovery, stability etc, which are in good agreement with the USFDA guidelines and are effectively applied to the investigation of the pharmacokinetic studies in rat plasma.
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