DEVELOPMENT AND VALIDATION OF AN LC-MS/MS METHOD FOR QUANTITATIVE DETERMINATION OF RITONAVIR IN HUMAN PLASMA USING SAQUINAVIR AS AN INTERNAL STANDARD

Niloufer Tasnim Khazi*, Bibi Fareesa Banu and Amreen Fatima

ABSTRACT

Pharmacokinetic studies play a crucial role in drug development, particularly in determining the bioavailability of active pharmaceutical ingredients. This research presents the development and validation of a sensitive and rapid high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the quantitative analysis of Ritonavir in human plasma. Saquinavir was used as an internal standard. The method involved simple liquid-liquid extraction and utilized a reverse-phase C18 column. Method validation was conducted in accordance with USFDA guidelines, evaluating parameters such as accuracy, precision, linearity, specificity, and stability. This method was successfully applied to pharmacokinetic studies, providing high selectivity and sensitivity for Ritonavir quantification in clinical trials.

Keywords: Ritonavir, Saquinavir, LC-MS/MS, pharmacokinetics, bioavailability, method validation, clinical trials.