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Chiral separation and quantitation of dorzolamide hydrochloride enantiomers by high‐performance liquid chromatography
Author(s) -
Shamsipur Mojtaba,
Heydari Rouhollah,
Jamasbi Elahe Sadat,
Abdollahpour Assem
Publication year - 2010
Publication title -
journal of separation science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.72
H-Index - 102
eISSN - 1615-9314
pISSN - 1615-9306
DOI - 10.1002/jssc.201000127
Subject(s) - dorzolamide , chromatography , enantiomer , chemistry , repeatability , ammonium acetate , high performance liquid chromatography , quantitative analysis (chemistry) , analytical chemistry (journal) , resolution (logic) , hydrochloride , detection limit , stereochemistry , organic chemistry , medicine , timolol , intraocular pressure , ophthalmology , artificial intelligence , computer science
A direct HPLC method for chiral separation of dorzolamide hydrochloride (4 S ,6 S ) and its enantiomer (4 R ,6 R ) was developed. Dorzolamide (4 S ,6 S ) and its antipode were separated on a chiral‐α 1 ‐acid glycoprotein column (150×4.0 mm, 5 μm). The influences of pH, temperature, flow rate, buffer concentration, and organic modifiers of the mobile phase on the retention and enantioselectivity were evaluated. The mobile phase consisted of an ammonium acetate buffer of pH 7.0. The method was validated for linearity, repeatability, accuracy, LOD, and LOQ. Calibration curves were constructed in the range of 0.5–10 μg/mL for dorzolamide (4 S ,6 S ) and 0.2–5 μg/mL for its enantiomer (4 R ,6 R ). Repeatability ( n =6) showed less than 2% RSD. LOD and LOQ of the two enantiomers were found to be 0.2 and 0.5 for dorzolamide (4 S ,6 S ), 0.05 and 0.2 for its enantiomer (4 R ,6 R ), respectively. The proposed method was applied to the determination of dorzolamide enantiomer (4 R ,6 R ) in a raw material and two different eye drop samples.