title: Development and validation of a reversed-phase HPLC method for the quantification of paclitaxel in different PLGA nanocarriers.
abstract: A reversed-phase high-performance liquid chromatography (RP-HPLC) method has been developed and validated for the quantification of paclitaxel encapsulated in biodegradable poly(lactic-co-glycolic) (PLGA) copolymer nanoparticles. This simple (isocratic mode, without additive) and rapid (retention time of the paclitaxel under 4 min) methodology permits the detection of low quantities of paclitaxel in nanoparticulate formulations and the determination of the encapsulation efficiency (EE). Analysis was achieved on an octadecyl stationary phase. The isocratic mobile phase consisted of acetonitrile:water 80:20 (v/v) (flow rate = 0.8 mL/min). Stability of free paclitaxel was preliminary studied in those chromatographic conditions. The calibration curve was linear in the concentration range of 2-10 μg/mL (R2= 0.9994). The method was specific with valuable trueness, repeatability (intra-day precision) and intermediate precision (inter-day precision) based on relative standard deviation (RSD) values (less than 2%). The limits of detection (LOD) and quantification (LOQ) were 0.56 and 1.85 ng/mL, respectively. This developed method was successfully employed for quantifying paclitaxel in PLGA 50:50 co-polymer nanoparticles. The accurate knowledge of the encapsulated paclitaxel concentration is essential to define the quantities of PLGA nanoparticles necessary to achieve the in vitro cell viability study.
authors.affiliation: Inserm, U995-LIRIC, Lille, France.|Faculté de Pharmacie, Plateforme de Binding, Université de Lille, U995-LIRIC, Lille, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Furman
authors.affiliation: Inserm, U995-LIRIC, Lille, France.|CHRU de Lille, U995-LIRIC, France.|Faculté de Médecine, Université de Lille, U995-LIRIC, Lille, France.
authors.forename: Rodolphe
authors.initials: R
authors.lastname: Carpentier
authors.affiliation: Inserm, U995-LIRIC, Lille, France.|Faculté de Pharmacie, Plateforme de Binding, Université de Lille, U995-LIRIC, Lille, France.|Faculté de Pharmacie, Institut de Chimie A. Lespagnol, Université de Lille, U995-LIRIC, Lille, France.
authors.forename: Amélie
authors.initials: A
authors.lastname: Barczyk
authors.affiliation: Inserm, U995-LIRIC, Lille, France.|Faculté de Pharmacie, Plateforme de Binding, Université de Lille, U995-LIRIC, Lille, France.|Faculté de Pharmacie, Institut de Chimie A. Lespagnol, Université de Lille, U995-LIRIC, Lille, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Chavatte
authors.affiliation: Inserm, U995-LIRIC, Lille, France.|CHRU de Lille, U995-LIRIC, France.|Faculté de Médecine, Université de Lille, U995-LIRIC, Lille, France.
authors.forename: Didier
authors.initials: D
authors.lastname: Betbeder
authors.affiliation: Inserm, U995-LIRIC, Lille, France.|Faculté de Pharmacie, Laboratoire de Chimie Analytique, Université de Lille, U995-LIRIC, Lille, France.
authors.forename: Emmanuelle
authors.identifier: 0000-0003-2304-2214
authors.initials: E
authors.lastname: Lipka
mesh_terms: D000970:Antineoplastic Agents / Q000032:analysis*; D002138:Calibration; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D056148:Chromatography, Reverse-Phase / Q000379:methods*; D004355:Drug Stability; D019073:HT29 Cells; D006801:Humans; D019344:Lactic Acid / Q000737:chemistry*; D057230:Limit of Detection; D061986:MCF-7 Cells; D053769:Nanocapsules; D017239:Paclitaxel / Q000032:analysis* / Q000494:pharmacology; D011100:Polyglycolic Acid / Q000737:chemistry*; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D013056:Spectrophotometry, Ultraviolet
chemical_list: D000970:Antineoplastic Agents; D053769:Nanocapsules; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D011100:Polyglycolic Acid; D019344:Lactic Acid; D017239:Paclitaxel
keywords: Encapsulation efficiency; PLGA-nanoparticle; Paclitaxel; RP-HPLC; Validation parameters