Development and Validation of Spectrophotometric Method for Estimation of Bivalirudin

In this research work we developed and validated UV spectrometric method for bivalirudin and it is simple, accurate, fast, cost efficient, reproducible method. This method developed for the estimation of bivalirudin in bulk and finished pharmaceutical dosage form. Based on measurement of absorption of UV light, the spectra of bivalirudin in water showed maximum absorption wavelength (λ max) at 276 nm. The calibration curve plotted over the concentration range from 2-20 μg/ml of bivalirudin with correlation coefficient 0.998. Validation was performed as per ICH Q2 guidelines for the linearity, accuracy, precision and recovery. Developed method has good reproducibility with % Relative Standard Deviation (RSD) less than one. Limit of detection (LOD) and Limit of Quantification (LOQ) were found to be 0.5892μg/ml and 1.785μg/ml respectively by simple UV Spectrophotometric. Thus proposed method can successfully applied for bivalirudin in routine analysis work.