HS-GC-FID Method Development and Validation for Quantification of Residual Solvents in Favipiravir

Abstract

Residual solvents testing is an important parts of quality control in pharmaceuticals and also essential part of reference material certification. In Pharmaceutical industry, in order to manufacture Favipiravir active pharmaceutical ingredient (API) the organic solvents like methanol, dichloromethane, acetonitrile and toluene is used often. According to ICH i.e., International Conference on Harmonization guidelines, the development, validation in order to identify the residual solvents in Favipiravir has been done using Head space gas chromatography having flame ionization detector. In this investigation, Agilent GC 7697A-FID detector and open labs EZ chrome software with auto injector was used for analysis. DB-624 column, (30m×0.53mm×1.4 µm coating thickness) was opted for separation where carrier gas is nitrogen and were performed at different temperature gradient programme. At range of 50-150% of standard concentrations for solvents were noted for linearity to estimate the amount of by the proposed methods was in linear. Method accuracy has been estimated at three different level by recovery studies percentage conducted at the absence of interference from the diluent and API. Method was proved to be precise as recommended by the repeatability and also showing %RSD less than 10 for solvents mentioned in the method. All statistical data shown the validity of the method. This proposed method is useful in the routine analysis of estimating residual solvents in Favipiravir API. All solvents’ baseline separation along with API was within 22.8 minutes. In the method ICH parameters were used to validate the developed method. The parameters for method validation namely specificity, limit of detection, limit of quantification, Accuracy, precision, linearity, ruggedness, robustness. The developed method was simple, sensitive, rugged, reliable, reproducible and effectively applied for quantifying specified limit levels for residual solvents in Favipiravir API and marketed formulation.