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

Volume : IV, Issue : IV, April - 2015

B. Sandhya, N. Srinivas, G. Tuljrani

A simple GC–HS method for the determination of residual solvents in fluconazole drug using

Nitrogen as the carrier gas at 2.8 mL/minwith ZB–624(30 meters X 0.53 mm ID) as column using FID as detector is

developed. The developed method is validated and the parameters are to be found within the limits of USP. The retention

time for residual solvents individually and in standard solution is determined. The %RSD for six injections is found to be NMT 15%. The correlation

coefficient R2 is found to be ≥ 0.999. The limit of detection and limit of quantification are found to be specific. Method precision is found to be

within the acceptance limit. The sample is tested for the presence of residual solvents mainly Methanol, Acetone, Dichloromethane, Ethyl acetate,

Toluene, and Isopropyl alcohol, which are found to be within ICH limits.