R. N. Mali

  Residual solvents in intermediates and active pharmaceutical ingredient were monitored by using gas chromatography. It is mandatory to control adequately the quality of active pharmaceutical ingredient by checking the levels of residual solvents. A systematic approach for the identification and quantification of residual solvents in citalopram hydrobromide was described in proposed analytical method. The analysis was carried  on DB624 (30 m x 0.32 mm id, 5 µm  coating thickness) capillary column by gas chromatography with flame ionization detector. It was validated as per ICH guidelines1. The method was validated for system suitability, specificity, LOD, LOQ, linearity, accuracy, precision and robustness. The method described was simple, sensitive, reliable and reproducible for the quantization of residual solvents at levels as per ICH guideline. Key words: Citalopram hydrobromide, Active pharmaceutical ingredient, Residual solvent, Gas chromatography