STABILITY INDICATIVE AND COST EFFECTIVE ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF FAVIPIRAVIR AND PERAMIVIR IN BULK AND PHARMACEUTICAL DOSAGE FORM BY USING RP-HPLC
Keywords:Favipiravir, Peramivir, RP-HPLC, Development, Validation
Objective: The current investigation was pointed at developing and progressively validating novel, simple, responsive and stable RP-HPLC method for the measurement of active pharmaceutical ingredients of Favipiravir and Peramivir and their related substances.
Methods: A simple, selective, validated and well-defined stability that shows gradient RP-HPLC methodology for the quantitative determination of Favipiravir and Peramivir. The chromatographic strategy utilized Inertsil ODS column of dimensions 250x4.6 mm, 5 micron, using isocratic elution with a mobile phase of acetonitrile and 0.1 percent orthophosphoric acid (70:30). A flow rate of 1 ml/min and a detector wavelength of 260 nm utilizing the PDA detector was given in the instrumental settings. Using the impurity-spiked solution, the chromatographic approach was streamlined.
Results: Validation of the proposed method was carried out according to an international conference on harmonization (ICH) guidelines. LOD and LOQ for the two active ingredients and their impurities were established with respect to test concentration. The calibration charts plotted were linear with a regression coefficient of R2>0.999, which means the linearity was within the limit. Recovery, specificity, linearity, accuracy, robustness, ruggedness was determined as a part of method validation and the results were found to be within the acceptable range.
Conclusion: The proposed method to be fast, simple, feasible and affordable in RS condition. During stability tests, it can be used for routine analysis of production samples and to verify the quality of drug samples during stability studies.
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