Related Experiment Videos
Selective stability-indicating high-performance liquid chromatographic assay for recombinant human regular insulin
G L Hoyer1, P E Nolan, J H LeDoux
1Department of Pharmacy Practice, College of Pharmacy, University of Arizona, Tucson 85721, USA.
Journal of Chromatography. A
|May 5, 1995
Summary
A new HPLC assay effectively separates recombinant human insulin from degradation products. This method ensures accurate insulin quantification for quality control and therapeutic monitoring.
Area of Science:
- Analytical Chemistry
- Biochemistry
- Pharmaceutical Analysis
Background:
- Recombinant human insulin is a critical therapeutic agent.
- Ensuring the purity and stability of insulin formulations is essential for patient safety.
- Identifying and quantifying insulin decomposition and transformation products is vital for quality control.
Purpose of the Study:
- To develop and validate a selective High-Performance Liquid Chromatography (HPLC) assay.
- To separate recombinant human regular insulin from its degradation products.
- To establish a reliable method for insulin purity assessment.
Main Methods:
- Utilized isocratic mobile phase delivery.
- Employed a C18 peptide column for separation.
- Incorporated UV detection at ambient temperature.
- Established a standard curve ranging from 0.2 to 2.5 U/ml.
Main Results:
- Achieved separation of recombinant human insulin from degradation products.
- Demonstrated inter-day variability below 7% and intra-day variability below 5%.
- Confirmed accuracy and precision within 5% across the standard curve range.
Conclusions:
- The developed HPLC assay is selective and reliable for analyzing recombinant human insulin.
- This method provides accurate quantification of insulin and its related impurities.
- The assay is suitable for routine quality control of insulin products.