METHOD DEVELOPMENT, VALIDATION, AND ESTIMATION OF AZILSARTAN KAMEDOXOMIL IN SPIKED HUMAN PLASMA Authors: Dumbare MR , WAGH MP, BORASTE PA, WAKHCHAURE AA, MORE AV, BORSATE SS AND TAJANE TH
ABSTRACT
Azilsartan Kamedoxomil (AK) was estimated from spiking human plasma using a quick and
easy reverse phase high-performance liquid chromatography (RP-HPLC) technique. The internal
standard Amlodipine Besylate (AB) and the analyte AK were extracted using diethyl ether. A
Hypurity C18 column (50 mm x 4.6 mm, particle size 5?m) was used for the chromatographic
separation, and the mobile phase was composed of buffer, acetonitrile, and methanol at a ratio
of 55:25:20 v/v/v at a flow rate of 0.8 ml/min. AK was extracted from human plasma using a
technique called liquid-liquid extraction. A wavelength of 249 nm was used for detection. The
procedure was approved in accordance with US-FDA guidelines for selectivity, precision,
accuracy, recovery, and stability. The AB retention time was determined to be 1.88 min, while
AK retention time was found to be 5.1 min. The calibration curve was discovered to be linear
between 0.1 and 1.5 g/mL. In tests of accuracy and precision, it was discovered that % relative
error was less than 15%. Finally, the suggested method is simple to apply, swift, dependable, and faster for analyzing AK in human plasma in a number of samples over a reasonable amount
of time in a cost-effective manner.
Keywords: Amlodipine besylate, Azilsartan kamedoxomil, Liquid-liquid extraction, High performance liquid chromatography, Validation Publication date: 01/12/2023 https://ijbpas.com/pdf/2023/December/MS_IJBPAS_2023_7605.pdfDownload PDFhttps://doi.org/10.31032/IJBPAS/2023/12.12.7605