title: Development and validation of RP-HPLC method: scope of application in the determination of oil solubility of paclitaxel.
abstract: A simple, reproducible, feasible and innovative reversed-phase high-performance liquid chromatographic method was developed and validated for the quantitative determination of paclitaxel dissolved in various oils. The method was validated after extraction of the analyte from capryol 90, triacetin and olive oil. The method was conducted on a Hypersil BDS C18 column, 250 × 4.6 mm, 5 µm particle size, with a mobile phase composed of acetonitrile: 10 mM KH2PO4 buffer (pH 3.5) (55:45, v/v) and detection at 227 nm. The linearity, in the range of 5 to 50 µg/mL, presented determination coefficients of 0.9983, 0.9997 and 0.9990 in capryol 90, triacetin and olive oil, respectively, calculated by the least-squares regression method. Intra-day precision values for percentages recovered were 0.68 to 0.80, 0.83 to 1.13 and 0.97 to 1.88, and inter day precision values were 1.52 to 1.92, 1.43 to 1.83 and 1.26 to 2.06 for capryol 90, triacetin and olive oil, respectively. The recovery of paclitaxel from the capryol 90, triacetin and olive oil ranged from 97.94 to 103.55, 96.85 to 103.27 and 97.14 to 103.64%, respectively. This developed and validated method was successfully applied to quantitatively assess paclitaxel dissolved in various oils. The solubility of paclitaxel was found to be higher in triacetin than in other tested oils.
authors.affiliation: 1Bioequivalence Study Centre, Department of Pharmaceutical Technology, Jadavpur University, Kolkata-700 032, India.
authors.forename: Hira
authors.initials: H
authors.lastname: Choudhury
authors.forename: Bapi
authors.initials: B
authors.lastname: Gorain
authors.forename: Sanmoy
authors.initials: S
authors.lastname: Karmakar
authors.forename: Tapan Kumar
authors.initials: TK
authors.lastname: Pal
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D056148:Chromatography, Reverse-Phase / Q000379:methods*; D016014:Linear Models; D009821:Oils / Q000737:chemistry*; D000069463:Olive Oil; D017239:Paclitaxel / Q000032:analysis* / Q000737:chemistry*; D010938:Plant Oils; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012995:Solubility; D014215:Triacetin
chemical_list: D009821:Oils; D000069463:Olive Oil; D010938:Plant Oils; D017239:Paclitaxel; D014215:Triacetin