Methyl Bromide Report

INTRODUCTION:

Itraconazole is a (1-(butan-2-yl)-4-{4-[4-(4-{[2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4 triazole-1- ylmethyl) 1, 3 – dioxolan – 4 -yl] methoxy}phenyl) piperazin -1-yl ] phenyl} 4, 4-dihydro-1H-1,2,4-triazole-5-one) is member of the drug class known as anti-fungal. It is used for the inhibition of fungal cytochrome p450 enzyme “lanosterol 4 demethylase”, used in the conversion of lanosterol to ergosterol, which is a main sterol in fungal cell membrane, thus inhibits replication and promotes cell death in case of the yeast cells transformation into hypothetically invasive hyphae. Literature survey revealed that very few methods have been reported for the analysis of Methyl Bromide in Itraconazole

The effect of variations in flow rate of carrier gas and Vail temperature was studied. Under all the variations, system suitability requirement is found to be within the acceptance criteria and hence the proposed method is robust. The relative standard deviation of area counts for Methyl Bromide peak obtained from six replicate injections of standard solution should be not more than 15.0%.The data of Robustness is following table.

Methyl Bromide Robustness (Flow variation)

System Suitability Parameter 2.59mL/min (Flow Minus) 3mL/min (Control) 3.5mL/min (Flow Plus) % RSD 6.5 5.11 7.21

Methyl Bromide Robustness (Vail Temperature variation)

System Suitability Parameter 35°C (Temperature Minus) 40°C (Control) 45°C (Temperature Plus) % RSD 7.37 7.07