Simultaneous Determination of Miconazole Nitrate and Metronidazole in Different Pharmaceutical Dosage Forms by Gas Chromatography and Flame Ionization Detector (GC-FID)

Abstract

A simple, rapid and precise gas chromatographic method has been developed for the simultaneous determination of miconazole nitrate (MIZ) and metronidazole (MNZ) in tablets and ovules, using a capillary column AE.SE-54 (15 m × 0.53 mm, i.d.) and nitrogen as a carrier gas at a flow rate of 9 mL min-1. The oven temperature was programmed at 140°C for 3 min, with a rise of 40°C min-1 up to 180°C (held for 2 min) and then increased to a final temperature of 250°C. The injector and detector port temperatures were maintained at 260°C. Detection was carried out using flame ionization detector. Results of assay and recovery studies were statistically evaluated for its accuracy and precision. The retention times were about 3.50 and 12.90min for MNZ and MIZ, respectively. Linearity ranges were 50.0-6030.0 and 62.5-2000.0 μg mL-1 for MNZ and MIZ, with limit of detection values of 2.5 and 3.1 μg mL-1, respectively. Correlation coefficients (R2) of the regression equations were greater than 0.999 in all cases. No interference from any components of pharmaceutical dosage forms or degradation products was observed. According to the validation results, the proposed method was found to be specific, accurate, precise and could be applied to the simultaneous quantitative analysis of MIZ and MNZ in tablets and ovules.