Abstract

DEVELOPMENT AND VALIDATION OF LC-MS/MS METHOD FOR QUANTIFICATION OF RALTEGRAVIR IN HUMAN PLASMA

Shravan Goski*, Dr. P. Venkatesh, Upendra Chowdary, N. Ajay Sai and T. S. R. K. V. Prasad

ABSTRACT

This study presents the development and validation of a liquid chromatography-mass spectrometry (LC-MS) method for the quantification of Raltegravir in Human Plasma Using Raltegravir 13C D3 as internal standard, an antiretroviral medication used in the treatment of HIV/AIDS. The method was optimized using a Unisol C18 4.6x100 mm 5μm column with a mobile phase consisting of acetonitrile and water with 0.1%formic acid(80:20v/v). The chromatographic separation was achieved with an isocratic elution, and the detection was performed using a mass spectrometer in positive ionization mode. The method demonstrated good linearity over the concentration range of 10 to 10000 ng/mL with a correlation coefficient (r). The developed method was validated for specificity, accuracy, precision, and stability according to regulatory guidelines. The intra-day and inter-day precision (%RSD) were within acceptable limits, demonstrating the method's reproducibility and reliability. The stability studies confirmed the integrity of Raltegravir in human plasma under various storage conditions. Furthermore, the validated method was successfully applied to quantify Raltegravir concentrations in plasma samples from pharmacokinetic studies, providing valuable data for drug monitoring and dose optimization in clinical settings. This LC-MS method offers a robust analytical tool for assessing Raltegravir pharmacokinetics and supporting therapeutic drug monitoring in HIV-infected patients.

Keywords: Raltegravir, LC-MS, Human Plasma.