Determination of enantiomeric impurity of timolol maleate in bulk substances and eye drops / 浙江大学学报·医学版

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>