Determination and Pharmacokinetics of Recombinant Human Growth Hormone in Rabbit Plasma by Spectrofluorometry Method

In this study, a new spectrofluorometry method was developed for the determination of human growth hormone (somatotropin) in rabbit plasma. The validation was assessed under a variety of conditions (FDA, Bioanalytical Method Validation Guidline). Calibration curves were linear between the concentration range of 0.125-8.0 mu g/mL. Intra- and inter-day precision values for somatotropin in plasma were less than 13.5, and accuracy (relative error) was better than 12.%. The recoveries for all samples were >84.0%. The limits of detection (LOD) and quantification (LOQ) of somatotropin were 0.075 and 0.10 mu g/mL, respectively. The described spectrofluorometry method has adequate sensitivity and specificity to study pharmacokinetics of somatotropin in rabbits, and could be adapted also to clinical pharmacokinetic study.