METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF CLASS II SLOVENTS IN LULICONAZOLE BY HSGC-FID

*Mohd. Khaja Yaqub Ali, Dr. V. Murali Balaram, M. Mushraff Ali Khan and Dr. Anupama Koneru

ABSTRACT

Method Development and validating the HS-Gas chromatography was carried on DB-624, (30mx0.53mm) 3.0micron column, using quantified solvents and by modifying the temp. of oven, flow of carrier gas with Flame ionization detector. The process was linear at 25-150 μg /ml for solvents Methanol, Cyclohexane, Methyl isobutyl ketone and Toluene (r2>0.999). So, developed method shows good agreement with increased conc. Levels of Luliconazole. Recovery studies determined at 50%, 100% and 150% levels, it was inferred to be in acceptance limits 80% to 120%. Precision performed with 6 replicates using the solvents Methyl isobutyl ketone, Tolune, Cyclohexane, methanol using DMSO as diluent was inferred that the RSD% in limits. Recovery experiments indicated the absence of interference from commonly encountered diluent and API. The method was found to be precise as indicated by the repeatability analysis, showing %RSD less than 10 for Methanol, Cyclohexane, Methyl isobutyl ketone and Toluen. The method found to be within limits for detection and quantification limit.

Keywords: Luliconazole, HS-GC, FID Detectors, Residual solvents.