Abstract
ENANTIOMERIC SEPARATION OF DORZOLAMIDE HYDROCHLORIDE BY A CHIRAL LIQUID CHROMATOGRAPHIC METHOD

Vinayak T. Vele*, Vishal Telvekar, Shivaji Kadam, Rupesh Kelaskar and Mohan A. Chandavarkar

ABSTRACT

Objective: To develop a simple chiral liquid chromatographic method to separate enantiomers of Dorzolamide hydrochloride. Methods: An enantioselective normal phase high performance liquid chromatographic method was developed and validated. The enantiomers of dorzolamide HCL was resolved on a Chiral pack AD-3 (250 mm x 4.6 mm, 3μm) column using a mobile phase system containing n-hexane, ethanol and diethylamine (80:20:0.1 v/v/v) and column temperature at 40°C. The resolution between the enantiomers was not less than 2.0. The developed method was validated according to ICH guidelines. Results: The calibration curve was found to be linear over the concentration range of 0.5–7.5μg/mL (r2= 0.9999). The limit of detection and limit of quantification of the (R)-enantiomer were found to be 0.15 and 0.5μg/mL, respectively, for 10 μL injection volume. The percentage recovery of the (R)-enantiomer ranged from 91.04 to 93.24 in bulk drug samples of dorzolamide HCL. The final optimized method was successfully applied to separate the (R)-enantiomer from dorzolamide HCL and was proved to be reproducible, accurate and robust for the quantitative determination of the (R)-enantiomer in Dorzolamide HCL. Conclusion: A novel, simple, selective and simple, selective and Enantiomeric separation of dorzolamide HCL by a chiral liquid chromatographic method was developed as per ICH guidelines. Hence, the method can be used for routine analysis in pharmaceutical industry.

Keywords: HPLC, dorzolamide HCL, Chiral, Enantiomeric separation, Validation.


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