ABSTRACT
An isocratic stability indicating liquid chromatographic method has been developed and validated for the determination of Rasagiline in bulk drug and its pharmaceutical dosage forms. Separation of the drug with degradation products was achieved using Puroshere Star, C18, 150 x 4.6mm; 5μm column as stationary phase and pH 7.0(±0.05) buffer: Acetonitrile (40:60,v/v) as mobile phase at a flow rate of 1.0 mL/min. UV detection was performed at 210 nm. The method is linear over the range of 4.8 – 150.5 μg/mL. The percent recovery of drug in dosage forms was ranged from 98.0 to 102.1. The method is simple, rapid, precise, selective and stability indicating and can be used for the assay in quality control and stability studies samples.
ABSTRACT
An LC method has been developed and subsequently validated for the determination of Ceftriaxone and Tazobactam for injection and its related substances in bulk and pharmaceutical formulation. Separation was achieved in isocratic mode using Kromasil, C18, 250 x 4.6 mm, 5 μm column with mobile phase A containing Potassium Dihydrogen Phosphate buffer (pH adjusted to 6.5±0.05 with Orthophosphoric acid),Citric acid buffer (pH adjusted to 5.0±0.05 with NaoH solution)and Acetonitrile and mobile phase B containing Tetradecyl ammonium bromide ,Tetraheptyl ammonium bromide and Acetonitrile at different time intervals as eluent at a flow rate 0.8ml/min. UV detection was performed at 230nm.The method is simple, selective and stability indicating .The described method is accurate and linear over a range of about 3.0289μg/mL to 9.0862μg/mL.The method precision for the determination of related impurities was below 5.0% RSD .The Percentage recoveries of known related impurities from dosage forms ranged from 87.3 to 112.5%. LOD and LOQ of all related impurities of Ceftriaxone and Tazobactam was established and ranged from 0.119μg/ml - 0.552μg/ml for LOD and 0.356μg/ml – 1.658μg/ml for LOQ .The method is useful in the quality control of bulk manufacturing and also in pharmaceutical formulations.