Development and Validation of RP-HPLC Method for Quantification of Total, Free and Entrapped Ritonavir in Lipid Nanocarriers and Drug content of Film Coated Fixed Dose Formulation

Abstract: Aim: The current study was aimed to develop and validate a simple isocratic, precise, sensitive, accurate robust reverse phase HPLC analytical method for the quantification of total, free entrapped ritonavir in lipid nanocarriers drug content film-coated fixed-dose formulation. Materials Methods: developed by using Inertsil ODS-3V C18 column as stationary phase, orthophosphoric acid (OPA) water (pH 3.0) acetonitrile mobile phase. Further, validated following ICH Q2(R1) guidelines. Ritonavir loaded were hot-emulsion probe-sonication method. A solid extraction (SPE) separation ritonavir. Total extracted from (LNCs) tablets methanol analyzed with Results: responses found be linear precise over range 0.25 μg/mL 16 μg/mL. limit detection (LOD) (LOQ) RP-HPLC 14.06 ng/mL 42.60 ng/mL, respectively which emphasizes sensitivity recovery LNCs within 3% total present LNCs. Similar, amount assay marketed formulation i.e., > 97%. Conclusion: SPE is capable separating robust, economical gives high recovery. can also employed routine quantitative analysis bulk Key words: method, Ritonavir, Validation, SPE, NLC, Bulk