Abstract

DEVELOPMENT AND VALIDATION OF BIOANALYTICAL RP-HPLC METHOD FOR TELMISARTAN USING LIQUID-LIQUID EXTRACTION

Laxman A. Kawale*, Tanmay H. Tajane, Vandana S. Nade, Madhavi P. Shinde, Amol V. More

ABSTRACT

A simple, accurate, sensitive and rapid reverse phase high performance liquid chromatography method has been developed for the quantification of telmisartan in human plasma using Liquid-liquid Extraction. The chromatographic method was developed using Chemsil ODS C18 column (250mm x 4.6 mm i.d, 5μ particle size), a mixture of phosphate buffer (pH 2.4): acetonitrile (60:40 % v/v) as mobile phase. at a flow rate of 1.0 ml/min with UV detection was caried out at 227nm. The retention time was found 4.2 min and 7.6 min for telmisartan and internal standard (Indapamide) respectively. Furthermore, bioanalytical method validation parameters such as system suitability, specificity, selectivity, linearity range, recovery, accuracy, precision, and stability were determined. The calibration curves were linear (r2=0.9999, n=6) over the concentration range 100-3200 ng/ml for telmisartan in human plasma. The average percentage recovery was found to be 88.44 w/v. The precision and accuracy were found within the limit. The LOQ value for a bio-analytical method of telmisartan was found to be 100 ng/ml. No, endogenous constituents were found to interfere at the retention time of the analysis. The proposed method is highly sensitive, precise, and accurate; hence it was successfully applied for the reliable quantification of telmisartan in human plasma.

Keywords: Human plasma, Telmisartan, Indapamide, Bioanalytical method, RP-HPLC.