ANAYTICAL METHOD DEVEOPMENT AND VAIDATION OF BUTYLATED HYDROXYTOLUENE IN ROSUVASTATIN TABLETS BY USING RP-HPLC

An RP-HPLC method was developed and validated for the estimation of Butylated Hydroxy toluene in Rosuvastatin Tablets. The chromatographic system was equipped with Hypersil BDS, C18, 250 X 4.6 mm, internal diameter with 5 micron particle size column and PDA detector set at 277nm, in conjunction with a mobile phase of Water and Methanol in the ratio of 100:900 at a flow rate of   0.8 ml/min. The retention time of Butylated Hydroxy toluene was found to be 7 minute. The separation was performed at ambient temperature. Linearity was observed in the concentration range of 2.5-7.5µg/ml with correlation co-efficient 0.999.Percentage recovery obtained 100.3%-100.8%. The percentage assay was found to be 99.8% .The proposed method is precise, accurate, selective and  rapid for the determination of Butylated Hydroxytoluene in Rosuvastatin Tablets. The proposed method is optimized and validated as per the International Conference on Hormonization (ICH) Guidelines. Key words: RP-HPLC, Butylated Hydroxytoluene , Rosuvastatin ,Validation