Abstract

BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF TELMISARTAN IN HUMAN PLASMA BY HPLC USING SOLID PHASE EXTRACTION TECHNIQUE

L. A. Kawale*, P. D. Ahire , V. S. Nade, A. K. Lade

ABSTRACT

A simple, robust and sensitive High-Performance liquid chromatography method was developed and validated for quantification of Telmisartan in human plasma. For this method, an aliquot 475 µL human plasma spiked with 25 µL Telmisartan and 50 µL of Amlodipine (IS); and was extracted by Solid Phase Extraction. The Agilent HPLC was used with control panel software. An Inertsil C18 column (150mm × 4.6mm ID, particle size: 5µ) was used to produce the separation. An isocratic mobile phase consisting of phosphate buffer and acetonitrile (55:45 %v/v) was used for separation of drug and IS using flow rate 1ml/min. 0.8 µL injection volume and UV detection at ⅄max 228 nm. The bioanalytical method is developed and validated as per ICH M10 and USFDA guidelines within the concentration range of 75 to 2400 ng/ml in human plasma with r2 =0.9994. Accuracy and precision are within the limit of standards for quality control samples and overall RSD. The intraday accuracy and precision were found in the range 98.11- 107.81% and 0.20-0.73% respectively. Furthermore, the interday accuracy and precision was found in the range of 98.08-100.19% and 1.47-3.19% respectively. Recovery of telmisartan was found to be 88.12%. Stability study was also performed as per regulatory guidelines.

Keywords: RP-HPLC, Human Plasma, Telmisartan, Amlodipine, Bioanalytical, Solid Phase extraction.