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.pdf
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https://doi.org/10.31032/IJBPAS/2021/10.9.1058