Abstract

S. B. Puranik*, Varun R. Pawar, N. Lalitha, P. N. Sanjay Pai and G. K. Rao

Gas chromatographic methods were developed and validated for the routine analysis of residual solvents in pharmaceuticals. Methods were compared for the simultaneous estimation of 6 residual solvents viz; methanol, ethanol, acetone, isopropyl alcohol, dichloromethane and toluene. The column of intermediate polarity BP-624 (6% cyanopropyl phenyl and 94% polysiloxine) eluted all six solvents within 8 min. The method has been compared by non polar column EC-5 (5% phenyl and 95% dimethyl polysilixone) column has elutedwithin 5 min and compared. Results indicated for simultaneous residual solvent analysis of solvents than, both column showed good resolution between the separated peaks. Methods were validated as per ICH method validation guidelines. The validation data of both the methods was compared and indicates both methods are sensitive, specific, precise and rugged for simultaneous residual solvents analysis of methanol, ethanol, acetone, isopropyl alcohol, dichloromethane and toluene.

Optimization; residual solvents; organic volatile impurities; gas chromatography

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