TY - JOUR
T1 - Quality control and stability study using HPTLC
T2 - Applications to cyclophosphamide in various pharmaceutical products
AU - Bouligand, Jérôme
AU - Storme, Thomas
AU - Laville, Isabelle
AU - Mercier, Lionel
AU - Oberlin, Odile
AU - Vassal, Gilles
AU - Bourget, Philippe
AU - Paci, Angelo
PY - 2005/6/1
Y1 - 2005/6/1
N2 - 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 50 mg 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 μg/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.
AB - 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 50 mg 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 μg/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.
KW - Cyclophosphamide
KW - HPTLC
KW - Quality control
KW - Stability study
UR - http://www.scopus.com/inward/record.url?scp=19444362393&partnerID=8YFLogxK
U2 - 10.1016/j.jpba.2004.12.001
DO - 10.1016/j.jpba.2004.12.001
M3 - Article
C2 - 15907638
AN - SCOPUS:19444362393
SN - 0731-7085
VL - 38
SP - 180
EP - 185
JO - Journal of Pharmaceutical and Biomedical Analysis
JF - Journal of Pharmaceutical and Biomedical Analysis
IS - 1
ER -