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High Performance Liquid-Chromatographic Determination Of Cetirizine In Pharmaceuticals

K.Basavaiah, B.C.Somashekar

One rapid assay procedure based on high performance liquid chromatography (HPLC) has been developed for cetirizine in bulk drug and in tablets. The determination was performed on a reversed phase column (ODS C18; 250x4.6 mm i.d) using a mobile phase(1.5 ml/min) consisting of potassium dihydrogen phosphate, acetonitrile and methanol (pH =5.5)-58:33:9(v/v) with UV-detection at 210 nm. A reactilinear relationship between mean peak area and concentration of CTH was observed in the range 2-30 g/ml with a detection limit of 0.2 g/ml and a quantitation limit of 0.66 g/ml. Intra-day and inter-day precision, and accuracy of the methods have been established according to the current ICH guidelines. The methods have been successfully applied to the assay of CTH in tablet preparations with recoveries varying from 99.8 to 101.9 % with standard deviation in the range of 0.68-1.12 %. The results were statistically compared with those of the reference method by applying Student’s t-test and F-test. Accuracy, evaluated by means of the spike recovery method was in the range 98.2 to 104.1 % with precision (RSD) better than 3%.