Back to Search
Start Over
Rapid resolution liquid chromatography for monitoring the quality of stockpiled atropine preparations for injection.
- Source :
-
Drug testing and analysis [Drug Test Anal] 2012 Mar-Apr; Vol. 4 (3-4), pp. 222-8. - Publication Year :
- 2012
-
Abstract
- We describe a rapid resolution liquid chromatography (RRLC) method for analyzing atropine sulfate, its degradation products (tropic acid, apoatropine, atropic acid) and other components (e.g. phenol, methylparaben) in injectable medicines that are used by the German armed forces in emergency situations. Chromatography is performed using an acetonitrile/phosphate buffer gradient (pH = 1.0) and an RP 18 column (50 x 4.6 mm, 1.8 µm) with the detection wavelength set at 220 nm. The concentration of the active ingredient (atropine sulfate) in the tested products ranges from about 1 mg•ml(-1) to 10 mg•ml(-1) . The concentrations of the detected degradation products range from 0.2% to 4.7% (tropic acid) in relation to the active pharmaceutical ingredient (API). Using shorter separation columns and smaller particle sizes of the stationary phase improved analysis time from 40 to 10 min and reduced the consumption of solvents by approximately 75%. Owing to the pressure conditions (< 200 bar), UHPLC (ultra high performance liquid chromatography) systems are not needed. Comparison of the atropine and tropic acid results obtained with the previously used HPLC (high performance liquid chromatography) method of the MAH (marketing authorization holder) show that there is no indication of a significant difference between the two methods.<br /> (Copyright © 2012 John Wiley & Sons, Ltd.)
- Subjects :
- Antidotes administration & dosage
Atropine administration & dosage
Chromatography, High Pressure Liquid economics
Drug Storage
Injections
Linear Models
Muscarinic Antagonists administration & dosage
Pharmaceutical Preparations chemistry
Quality Control
Sensitivity and Specificity
Time Factors
Antidotes analysis
Atropine analysis
Chromatography, High Pressure Liquid methods
Muscarinic Antagonists analysis
Subjects
Details
- Language :
- English
- ISSN :
- 1942-7611
- Volume :
- 4
- Issue :
- 3-4
- Database :
- MEDLINE
- Journal :
- Drug testing and analysis
- Publication Type :
- Academic Journal
- Accession number :
- 22467254
- Full Text :
- https://doi.org/10.1002/dta.402