title: Quality control and stability study using HPTLC: applications to cyclophosphamide in various pharmaceutical products.
abstract: Cyclophosphamide is an alkylating agent widely used from cancer chemotherapy to immunotherapy purposes. In paediatrics oncology, oral cyclophosphamide prescribed at low dosages for a long time treatment is currently investigated. This treatment is a putative well tolerated regimen for children treated for a wide variety of recurrent solid tumours. For these purposes, new oral formulations more convenient for children than cyclophosphamide 50mg tablets are needed. Thus, we present a rapid method for the assay of cyclophosphamide in various pharmaceutical preparations using high-performance thin-layer chromatography (HPTLC) and derivatization with phosphomolybdic acid. This method is accurate and precise and allows quantitation of cyclophosphamide in aqueous solutions from 400 to 1200 microg/mL. It is suitable for quantitation and stability studies of cyclophosphamide in pharmaceutical products, i.e. capsules and infusion bags prepared in a hospital pharmacy. According to pharmaceutical guidelines, we demonstrated that low dose cyclophosphamide capsules, extemporaneously prepared for children, are stable at least for 70 days.
authors.affiliation: Department of Clinical Pharmacy, Institut Gustave Roussy, 39 rue Camille Desmoulins, 94800 Villejuif, France.
authors.forename: Jérôme
authors.initials: J
authors.lastname: Bouligand
authors.forename: Thomas
authors.initials: T
authors.lastname: Storme
authors.forename: Isabelle
authors.initials: I
authors.lastname: Laville
authors.forename: Lionel
authors.initials: L
authors.lastname: Mercier
authors.forename: Odile
authors.initials: O
authors.lastname: Oberlin
authors.forename: Gilles
authors.initials: G
authors.lastname: Vassal
authors.forename: Philippe
authors.initials: P
authors.lastname: Bourget
authors.forename: Angelo
authors.initials: A
authors.lastname: Paci
mesh_terms: D002138:Calibration; D002855:Chromatography, Thin Layer / Q000379:methods*; D003520:Cyclophosphamide / Q000032:analysis*; D004355:Drug Stability; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D011786:Quality Control; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D004364:Pharmaceutical Preparations; D003520:Cyclophosphamide