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The determination of busulphan in dissolution samples by flow injection analysis.
A D Dow1, G Finlay, M S Bloomfield
1Pharmaceutical Development, GlaxoWellcome Research and Development, Hertfordshire, UK. AD47219@ggr.co.uk
Journal of Pharmaceutical and Biomedical Analysis
|March 7, 2000
Summary
A new colorimetric method accurately measures busulphan in tablets using flow injection analysis (FIA). This validated technique is suitable for quality control testing of busulphan formulations.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Analysis
Background:
- Busulphan is a key chemotherapeutic agent.
- Accurate quantification of busulphan is essential for pharmaceutical quality control.
Purpose of the Study:
- To develop and validate a robust colorimetric flow injection analysis (FIA) method for busulphan determination.
- To apply the method for busulphan analysis in tablet dissolution samples.
Main Methods:
- Direct injection of sample into a reagent stream containing 4-(4-nitrobenzyl)pyridine/potassium hydrogen phthalate.
- On-line heating for colored pyrridinium salt formation.
- Spectrophotometric detection at 570 nm.
Main Results:
- The method is linear over the concentration range of 0.004–0.024 mg/ml.
- The colorimetric FIA procedure is robust and fully validated.
- The method demonstrated applicability to uniformity of content and bulk assay testing.
Conclusions:
- A reliable and efficient colorimetric FIA method for busulphan determination in pharmaceutical formulations has been established.
- This validated method can be utilized for routine quality control of busulphan tablets.