Quality control and stability study using HPTLC: applications to cyclophosphamide in various pharmaceutical products.
J Pharm Biomed Anal
; 38(1): 180-5, 2005 Jun 01.
Article
em En
| MEDLINE
| ID: mdl-15907638
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.
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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Preparações Farmacêuticas
/
Cromatografia em Camada Fina
/
Ciclofosfamida
Tipo de estudo:
Diagnostic_studies
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Guideline
Idioma:
En
Revista:
J Pharm Biomed Anal
Ano de publicação:
2005
Tipo de documento:
Article
País de afiliação:
França