Determination of enantiomeric impurity of timolol maleate in bulk substances and eye drops / 浙江大学学报·医学版
Journal of Zhejiang University. Medical sciences
;
(6): 160-163, 2014.
Article
in Chinese
| WPRIM
| ID: wpr-336725
ABSTRACT
<p><b>OBJECTIVE</b>To determine the enantiomeric impurity contents of domestic timolol maleate in bulk drugs and eye drops.</p><p><b>METHODS</b>Enantiomer impurity of timolol was assayed by chiral high performance liquid chromatography. The chromatographic conditions were as followschiralcel OD chiral column (4.6 mm ×150 mm, 5μm), detection wavelength297 nm, mobile phasehexane-isopropanol-diethylamine (480201), column temperature25 ℃, flow rate1.0 ml/min, sample injection volume5 μl.</p><p><b>RESULTS</b>The resolution between R- and S-timolol was more than 4. The enantiomeric impurity contents were less than 0.67% on average in two batches of timolol maleate bulk drugs, and 0.31% on average in three batches of timolol maleate eye drops.</p><p><b>CONCLUSION</b>Enantiomeric impurity contents in each batch of products all meet European Pharmacopoeia criteria, which can be used as references in Chinese Pharmacopoeia criteria.</p>
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Ophthalmic Solutions
/
Reference Standards
/
Stereoisomerism
/
Timolol
/
Drug Contamination
/
Chromatography, High Pressure Liquid
/
Methods
Language:
Chinese
Journal:
Journal of Zhejiang University. Medical sciences
Year:
2014
Type:
Article
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