Abstract

DEVELOPMENT AND VALIDATION OF BIOANALYTICAL METHOD FOR BILASTINE BY RP-HPLC ON RAT PLASMA

Ashish Chaudhari*, Mohit Raut, Vivek Harbade, K. B. Gabhane and S. D. Pande

ABSTRACT

A rapid, sensitive and selective HPLC method for the determination of Bilastine in rat plasma was developed and validated. Sample preparation was assured by protein precipitation method. Separation was occurred on a Zodiac-100 C-18 RP column (150 cm x 4.6 mm, 5μm ID) with a mobile phase 0.5% Trifluoroacetic Acid and Acetonitrile: (80:20%v/v) pH 3.5 adjusted with orthophosphoric acid and was eluted at a flow rate of 1.0mL min-1 and the detection was done at 254 nm. The standard curve was linear over the concentration range of 15.6-500 μg /ml. The limit of quantification (LOQ) and limit of detection (LOD) of Pirfenidone was found to be 12.14 ng mL-1 and 36.79ng mL-1 respectively. The validation parameters of accuracy and precision study were performed at two levels such as intra-day and inter-day. The developed method shows good accuracy and precision. Accuracy ranges from 98.49% to 99.37% with the precision 0.26 – 1.22% in inter-day method. Intra-day method the accuracy ranges from 98.64% to 99.33% with the precision 0.61 – 1.44 %. Hence, the developed RP-HPLC method can be adopted for the routine analysis of Bilastine in bulk and pharmaceutical dosage form in quality control laboratories. This method was successfully applied for estimation of Bilastine in Rat plasma.

Keywords: Method development, RP-HPLC, Bilastine, Method Validation, Bioanalytical.