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An accurate and novel method was developed for the determination of residual solvents of Cloxacillin and Dicloxacillin 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 Meter long and 0.32 mm in internal diameter. Beer’s law is obeyed in the concentration ranges of Methanol, Ethyl Acetate and Toluene 200 – 3000, 100 – 1000, 100 – 500 ppm and 50 – 2000, 50 – 1000, 50 – 500 ppm for Cloxacillin and Dicloxacillin Sodium respectively. 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 0.9978, 0.9972, 0.9838 and 0.9872, 0.9969, 0.9883 respectively for Cloxacillin and Dicloxacillin Sodium.

A sensitive head space gas chromatographic method for the determination of residual solvents of cloxacillin sodium and dicloxacillin sodium