Quality control and stability study using HPTLC: applications to cyclophosphamide in various pharmaceutical products

J Pharm Biomed Anal. 2005 Jun 1;38(1):180-5. doi: 10.1016/j.jpba.2004.12.001.

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.

Publication types

  • Validation Study

MeSH terms

  • Calibration
  • Chromatography, Thin Layer / methods*
  • Cyclophosphamide / analysis*
  • Drug Stability
  • Pharmaceutical Preparations / chemistry*
  • Quality Control
  • Reproducibility of Results
  • Sensitivity and Specificity

Substances

  • Pharmaceutical Preparations
  • Cyclophosphamide