Development and validation for the determination of residual solvents of pharmaceutical formulations of flucloxacillin sodium using head space gas chromatography

摘要

An accurate and novel method was developed for the determination of residual solvents of flucloxacillin sodium by using head space gas chromatography (HSGC). The determination was done on Clarus 400 (PerkinElmer) with Total Chrome Navigator software. The residual solvents were separated on Elite - 5 fused silica capillary column 30 m long and 0.32 mm in internal diameter. Beer’s law is obeyed in the concentration ranges of methanol, ethyl acetate and toluene 50 to 2000, 50 to 1000, 100 to 500 ppm for flucloxacillin sodium. The method was validated for specificity, linearity, precision, accuracy, limit of detection, limit of quantitation, robustness and solution stability. The degrees of linearity of the calibration curves, the percent recoveries, relative standard deviation for the method were determined. The correlation coefficient for methanol, ethyl acetate and toluene are found as 0.9956, 0.9941 and 0.9863 for flucloxacillin sodium.