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Abstract

An accurate analytical method was developed using headspace gas chromatography for the determination of residual solvents in metformin hydrochloride and hydrochlorothiazide. The residual solvent was studied with the help of gas chromatography (Shimadzu 2014 model) combined with Teledyne Tekmar headspace and GC solution software. The residual solvents were separated using DB-WAX column 30-meter-long, 0.32mm internal diameter for metformin hydrochloride and BP624 column 30-meter-long, 0.53 mm internal diameter for hydrochlorothiazide. The limit of detection and limit of quantitation of dimethylacetamide, methanol and benzene were 17.00, 10.93, 0.18 and 51.92, 33.13, 0.57 ppm respectively for metformin hydrochloride and in case of hydrochlorothiazide, the values were 3.40& 1.30 ppm and 10.15 & 4.00 ppm for methanol and methyl isobutyl ketone respectively. The method was validated according to international conference on harmonization guideline in terms of specificity, linearity, precision, accuracy and robustness.

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