Stability Indicating RP-HPLC Method Development and Validation for Quantification of Favipiravir and its Related Substances.

Background: Favipiravir is an influenza antiviral medication. DEM Avigan is the commercial name for a pyrazine carboxamide derivative. Aim: According to the guidelines framed by ICH - International Council for Harmonisation, the present method was developed and validated for the system suitability, specificity, linearity, precision, limit of quantification and limit of detection, accuracy, & robustness. Results: All the results obtained were within the acceptable range. This method was used to better separate the peaks of Favipiravir and its three impurities. The retention times and squared correlation coefficient values of Impurity-1, Impurity-2, Favipiravir & Impurity-3 were obtained at 1.998, 3.223, 4.438 & 7.052 min and 0.9993, 0.9995, 0.9998 & 0.9997 respectively. Conclusion: Thus, the results show that the suggested RP-HPLC method for separating three contaminants with Favipiravir was effective and may be utilised in routine pharmaceutical analysis and quality control. Forced degradation was carried out under different stress conditions thus proving as stability indicating as per ICH guidelines.