Author(s): V Anil Kumar, G Aravind, I Srikanth, A Srinivasarao, Ch Dharma Raju
The purpose of this research study was to develop a nd optimize an accurate and precise GC method for t he determination of Residual solvents (n-Hexane, Metha nol, Isopropyl Alcohol, Toluene, O-Xylene, DMF & Ac etic acid) in Amoldipine besylate using the DB-FFAP, 30 m x 0.53mm ID, 1.0 μm column as stationary phase. T he injection volume of samples taken is 1 μl. The spli t ratio of the injection was 1:10. The temperature maintained at the injector and detector was to be 220ºC and 260ºC respectively. Nitrogen gas having make up flow 40 ml/ minute and having column flow 2.8 ml/minute used as mobile phase and the detection was by FID. The flow of hy drogen and Air was maintained at 30ml/min and 300ml/min re spectively. The diluent used is Dimethyl Sulfoxide. All solvents well resolved each other with diluents pea k RT at 21 min in total run time of 24.25 min. The RTs observed for the Residual solvents n-Hexane, Methanol, Isopr opyl Alcohol, Toluene, O-Xylene, DMF & Acetic acid are 3.03, 6.20, 6.87, 10.27, 14.57, 17.49 &19.54 respectively . The method was validated as meets the all regulat ions of System suitability, Specificity, Method Precision, Linearity, LOD & LOQ, Precision of LOQ and Accuracy /Recovery under ICH specifications.