[Determination of enantiomeric impurity of timolol maleate in bulk substances and eye drops].
Zhejiang Da Xue Xue Bao Yi Xue Ban
; 43(2): 160-3, 2014 03.
Article
in Zh
| MEDLINE
| ID: mdl-24782371
ABSTRACT
OBJECTIVE:
To determine the enantiomeric impurity contents of domestic timolol maleate in bulk drugs and eye drops.METHODS:
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 â, flow rate1.0 ml/min, sample injection volume5 µl.RESULTS:
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.CONCLUSION:
Enantiomeric impurity contents in each batch of products all meet European Pharmacopoeia criteria, which can be used as references in Chinese Pharmacopoeia criteria.
Search on Google
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Ophthalmic Solutions
/
Timolol
/
Drug Contamination
/
Chromatography, High Pressure Liquid
Language:
Zh
Journal:
Zhejiang Da Xue Xue Bao Yi Xue Ban
Journal subject:
MEDICINA
Year:
2014
Document type:
Article
Affiliation country:
China