Bio-analytical Method Development for Pharmacokinetic Study of Novel Lafutidine Formulation in Rabbit Plasma Using RP-HPLC

Abstract:

Objectives: The main objective of the study is to carry out comparative in vivo pharmacokinetic study of novel formulation with marketed formulation of lafutidine using HPLC method. Materials and Methods: The animals were selected according to the study protocol and divided in to three groups. The animals were given lafutidine marketed and novel formulation orally; at predetermined time blood samples were collected and subjected to the protein precipitation to collect blood plasma. The plasma samples were analysed using validated RP- HPLC method. Analysis of plasma was done at 215 nm using Hypersil silica, C18 250×4.6 mm. 5µ 0.02 M phosphate buffer and acetonitrile at 30:70 v/v was selected as mobile phase and passed at flow rate of 1.0 mL/min. Results: The established method was specific and sensitive for plasma sample. Calibration curve was developed using concentration range of 50-200 ng/mL with correlation coefficient of 0.9993. The accuracy the intra and inter day precision was found 100.26 and 98.02% with percent accuracy 98.41% to 100.77% and 98.23% and 99.67%. Conclusion: The developed method is able to meet all specifications and reproducible to identify and quantify the lafutidine in rabbit plasma and can applied to study pharmacokinetic parameters.

Keywords: In vivo study, Pharmacokinetic, Novel formulation, Rabbit plasma, HPLC.DIA.