Volume : 4, Issue : 4, April - 2015

DEVELOPMENT AND VALIDATION OF GC-HS METHOD FOR THE DETERMINATION OF RESIDUAL SOLVENTS IN FLUCONAZOLE

B. Sandhya, N. Srinivas, G. Tuljrani

Abstract :

<p>&nbsp;A simple GC&ndash;HS method for the determination of residual solvents in fluconazole drug using</p> <div>Nitrogen as the carrier gas at 2.8 mL/minwith ZB&ndash;624(30 meters X 0.53 mm ID) as column using FID as detector is&nbsp;</div> <div>developed. The developed method is validated and the parameters are to be found within the limits of USP. The retention&nbsp;</div> <div>time for residual solvents individually and in standard solution is determined. The %RSD for six injections is found to be NMT 15%. The correlation&nbsp;</div> <div>coefficient R2 is found to be &ge; 0.999. The limit of detection and limit of quantification are found to be specific. Method precision is found to be&nbsp;</div> <div>within the acceptance limit. The sample is tested for the presence of residual solvents mainly Methanol, Acetone, Dichloromethane, Ethyl acetate,&nbsp;</div> <div>Toluene, and Isopropyl alcohol, which are found to be within ICH limits.</div>