Development and Validation of Spectrophotometric Method for Estimation of Bivalirudin

Research Article

Austin J Anal Pharm Chem. 2014;1(5): 1024.

Development and Validation of Spectrophotometric Method for Estimation of Bivalirudin

Shivaraj D Sadekar1*, Ramchandra N Chilkawar2, S M Patil1, J K Saboji1, Basavaraj K Nanjwade3

1Department of Pharmaceutics, KLE College of Pharmacy, India

2Department of Quality Assurance, Remidex Pharma Pvt Ltd., India

3Department of Pharmaceutics, Omer Al-Mukhtar University, Libya

*Corresponding author: :Mr. Shivraj D Sadekar, Department of pharmaceutics, India.

Received: October 02, 2014; Accepted: November 06, 2014; Published: November 13, 2014


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.

Keywords: Bivalirudin; Spectrophotometric; Method; ICH Q2 guidelines


Chemically Bivalirudin is a synthetic 20 residue peptide (thrombin inhibitor) which reversibly inhibits thrombin. Once bivalirudin, thrombin inhibitor bound to the active site and thrombin cannot activate fibrinogen into fibrin and the crucial step in the formation of thrombus. It is has been administered intravenously because it can cause blood stagnation and it is important to monitor changes in hematocrit, international normalized ratio and blood pressure. Activated partial thromboplastin time, its chemical formula C98H138N24O33 and molecular weight is 2180.28 (Figure 1).