Quantification of raltegravir (MK0518) in human plasma by high-performance liquid chromatography with photodiode array detection.
A precise and accurate high-performance liquid chromatography (HPLC) method with photodiode array detection has been developed and validated for raltegravir, a human immunodeficiency virus integrase strand transfer inhibitor (HIV-1 INSTI). Plasma (300 microL) was extracted with dichloromethane/hexane 50:50 (v/v) after addition of the internal standard, 6,7-dimethyl-2,3-di(2-pyridyl) quinoxaline. The compounds were separated using a dC18 column and detected with ultraviolet detection at 320 nm. The limit of quantification was 10 ng/mL for raltegravir. The method was linear and validated over a concentration range of 0-10,000 ng/mL. The intra-day precision ranged from 3.1 to 12.3%, while the intra-day accuracy ranged from -15.0 to -0.5%, the inter-day precision and accuracy were less than 7%. The mean recovery was 76.8%. Application to clinical samples taken from patients treated with raltegravir indicated that the method is suitable for measuring plasma concentrations of raltegravir in pharmacokinetic studies of clinical trials.
Goldwirt
Lauriane
L
Pharmacie Clinique, Laboratoire de Toxicologie, CHU de Bicêtre AP-HP, 78 avenue du Général Leclerc, 94270 Le Kremlin-Bicêtre, France.
Barrail-Tran
Aurélie
A
Da Cruz
Maria
M
Taburet
Anne-Marie
AM
Furlan
Valérie
V
D000998:Antiviral Agents / Q000097:blood*; D002138:Calibration; D002851:Chromatography, High Pressure Liquid / Q000295:instrumentation* / Q000379:methods*; D004355:Drug Stability; D006801:Humans; D057230:Limit of Detection; D010777:Photochemistry / Q000295:instrumentation*; D011760:Pyrrolidinones / Q000097:blood*; D000068898:Raltegravir Potassium
D000998:Antiviral Agents; D011760:Pyrrolidinones; D000068898:Raltegravir Potassium