AN LC-MS/MS METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF FOSAMPRENAVIR IN BIOLOGICAL SAMPLES Authors: Bandaru Anil Kumar, Bomma Ramesh*
ABSTRACT
The main aim of the present work was to develop a sensitive liquid chromatography-electrospray
ionization tandem mass spectrometric technique for the quantitation of fosamprenavir in
biological matrices. Chromatographic elution was attained thru a Phenomenex C18 stationary
column having the dimensions of 50 × 4.6 mm and particle size of 5 ?m. Isocratic elution was
processed with 0.1%V/V formic acid and methanol in the ratio of 25:75 V/V as mobile phase
with flow rate of 0.70 ml/min. Liquid-liquid extraction was performed for drug and internal
standard isolation with an ethyl acetate and methanol (4:1) solvent system. Parent and product
ions were monitored at m/z 586.19?57.07 for fosamprenavir and 420.1?136.0 for
dolutegravir internal standard on multiple reaction monitoring. Linearity graph of drug was
rectilinear in concentration over 1.0. to 2100.0 ng/ml having r2
(correlation coefficient) value
more than 0.999. Percentage of RSD findings were ?3.081% for inter and intraday accuracy and
precision. This procedure has good recoveries and %recovery findings of lower quality control
(LQC), median quality control (MQC) and higher quality control(HQC) samples were 97.35%,
98.61% and 102.65% respectively. Fosamprenavir has more stability for longer time when subjected for different stability environments and the technique was effectively relevant to
routine analysis of fosamprenavir in biological matrix.
Keywords: HIV, Fosamprenavir , LC-MS/MS, FDA guidelines, Accuracy, Precision
Publication date: 25/09/2021 https://ijbpas.com/pdf/2021/September/MS_IJBPAS_2021_SEPT_SPCL_1058.pdfDownload PDFhttps://doi.org/10.31032/IJBPAS/2021/10.9.1058