Stability Indicating LC-MS/MS Method Development and Validation for the Quantification of Cabotegravir in Biological Samples

Abstract

The major goal of current research study was to create a sensitive tandem mass spectrometric method using electrospray ionisation and liquid chromatography for quantifying cabotegravir in biological matrices. A stationary Phenomenex C18 column with dimensions of 50 × 4.6 mm and 5.0 μm particle size of was used to achieve chromatographic elution. With the flowing rate of 0.80 mL/min, isocratic separation was done using methanol and 0.10% V/V HCOOH in a fraction of 85:15 V/V as the mobile phasic system. For drug and internal standard separation, liquid-liquid extraction was carried out using methanol and ethyl acetate (1:4) solvent solution. On repeated reaction monitoring, fragment and product ionic values were seen at m/z 406.12→142.04 for cabotegravir and 450.12→160.03 for bictegravir internal standard. Drug’s linearity graph had a r2 value of 0.9998 and was rectilinear at concentrations between 400 and 16000 ng/mL. The inter- and intra-batch accuracy %relative standard deviation values ranged from 2.54 to 5.21. The percent recovery results of the lower quality control (LQC), median quality control (MQC), and higher quality control (HQC) sample solutions were 102.85, 97.84, and 94.27%, respectively. This approach has excellent recoveries. Studies on stability were processed under various circumstances, and stability values ranged from 92.93 to 103.89%. When exposed to various stability conditions, cabotegravir is more steady for a longer time, and the approach was successfully applicable to routine examination of cabotegravir in biological samples.