Development and validation of reverse phase HPLC method for determination of angiotensin receptor blocking agent irbesartan in plasma

Pak J Pharm Sci. 2019 Mar;32(2 (Supplementary)):853-858.

Abstract

A sensitive, reproducible and modest analytical procedure was developed and validated for evaluation of irbesartan in human plasma. LLE (Liquid-Liquid extraction) of the drug was carried out with acetonitrile (1:1 v/v). Chromatographic separation of irbesartan was conducted by the help of 4.0mm × 25cm column having L1 packing from plasma and mobile phase utilizing HPLC. The mobile phase comprise of phosphate buffer and acetonitrile in a ratio of 67:33 v/v. The flow rate was set at 1ml/minute and the detector at a wavelength of 220 nm. The resolution of irbesartan was well performed from plasma components. This method was validated and demonstrated linearity with a concentration range of 0.1to 6μg/ml of irbesartan in plasma. Intra-day, inter-day accuracy was found 89.33% to 96.37% while intra-day, inter-day precision was found within the limit of 0.02 and 2.15 respectively. The mean recovery of irbesartan was 97.28%. The efficacy of extraction was proved by above-mentioned results. In plasma, the 0.05 and 0.1μg/ml dilutions were exhibited as the LOD and LOQ of irbesartan. Stability studies disclosed that irbesartan showed stability at -20°C storage.

Publication types

  • Validation Study

MeSH terms

  • Angiotensin II Type 1 Receptor Blockers / blood*
  • Angiotensin II Type 1 Receptor Blockers / pharmacokinetics
  • Calibration
  • Chromatography, High Pressure Liquid / methods*
  • Chromatography, Reverse-Phase / methods
  • Drug Stability
  • Humans
  • Irbesartan / blood*
  • Irbesartan / pharmacokinetics
  • Limit of Detection
  • Sensitivity and Specificity

Substances

  • Angiotensin II Type 1 Receptor Blockers
  • Irbesartan