BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTIFICATION OF CIPROFLOXACILIN HCL IN PLASMA BY HPLC.

Mallikarjuna Gouda M.* and Ramakrishna Shabaraya A.

ABSTRACT

The development of sound bioanalytical method is an important paramount process in drug discovery, development and in pharmacokinetics of drug. In the present investigation the HPLC bioanalytical method of liquid- liquid extraction of drug from plasma is established and the linearity study of Ciprofloxacilin HCl was found in range of 0.5 μg/ml to 4 μg/ml, the regression equation was found to be y = 1326.3X + 7.4819. The method checked for Pression and % RSD was found to be 1.45 % and the accuracy was in the range 101.0% to 102.40%. The limit of detection and the limit of quantification were calculated by the non instrumental that is by equation mentioned in the methodology. The LOD was found to be 0.039 μg/ml and LOQ was found to be 0.11 μg/ml. Thus the developed bioanalytical HPLC is selective and quantity the Ciprofloxacilin HCL in plasma and supports the pharmacokinetics of colon targetd Ciprofloxacilin HCl matrix tablets.

Keywords: Ciproloxacillin HCl, Leveoloxacillin, Linearity, Precession, Relative standard deviation, Plasma drug concentration.