title: HPLC method for determination of SN-38 content and SN-38 entrapment efficiency in a novel liposome-based formulation, LE-SN38.
abstract: A simple HPLC method was developed for quantification of SN-38, 7-ethyl-10-hydroxycamptothecin, in a novel liposome-based formulation (LE-SN38). The chromatographic separation was achieved on an Agilent Zorbax SB-C18 (4.6 mmx250 mm, 5 microm) analytical column using a mobile phase consisting of a mixture of NaH2PO4 (pH 3.1, 25 mM) and acetonitrile (50:50, v/v). SN-38 was detected at UV wavelength of 265 nm and quantitatively determined using an external calibration method. The limit of detection (LOD) and limit of quantitation (LOQ) were found to be 0.05 and 0.25 microg/mL, respectively. The individual spike recovery of SN-38 ranged from 100 to 101%. The percent of relative standard deviation (%R.S.D.) of intra-day and inter-day analyses were less than 1.6%. The method validation results confirmed that the method is specific, linear, accurate, precise, robust and sensitive for its intended use. The current method was successfully applied to the determination of SN-38 content and drug entrapment efficiency in liposome-based formulation, LE-SN38 during early stage formulation development.
authors.affiliation: Hospira, Inc., 275 North Field Drive, Lake Forest, IL 60045, USA.
authors.forename: Tong
authors.initials: T
authors.lastname: Xuan
authors.forename: J Allen
authors.initials: JA
authors.lastname: Zhang
authors.forename: Imran
authors.initials: I
authors.lastname: Ahmad
mesh_terms: D000097:Acetonitriles / Q000737:chemistry; D000972:Antineoplastic Agents, Phytogenic / Q000032:analysis*; D002021:Buffers; D002166:Camptothecin / Q000031:analogs & derivatives* / Q000032:analysis; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D006863:Hydrogen-Ion Concentration; D000077146:Irinotecan; D008081:Liposomes / Q000737:chemistry*; D015203:Reproducibility of Results; D013696:Temperature
chemical_list: D000097:Acetonitriles; D000972:Antineoplastic Agents, Phytogenic; D002021:Buffers; D008081:Liposomes; D000077146:Irinotecan; D002166:Camptothecin; C032159:acetonitrile