Quality control and stability study using HPTLC: applications to cyclophosphamide in various pharmaceutical products.
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.
Bouligand
Jérôme
J
Department of Clinical Pharmacy, Institut Gustave Roussy, 39 rue Camille Desmoulins, 94800 Villejuif, France.
Storme
Thomas
T
Laville
Isabelle
I
Mercier
Lionel
L
Oberlin
Odile
O
Vassal
Gilles
G
Bourget
Philippe
P
Paci
Angelo
A
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
D004364:Pharmaceutical Preparations; D003520:Cyclophosphamide