Determination of stability indicating assay method for eszopiclone in pharmaceutical drug substances a comparative study by UPLC and HPLC.

Author(s): Hanumanturayudu K*, Sreeramulu J., Maheswara Reddy M.

Abstract

Eszopiclone is a nonbenzodiazepine hypnotic used as a treatment for insomnia. Eszopiclone is the active dextrorotatory stereoisomer of zopiclone, and belongs to the class of drugs known as cyclopyrrolones. A simple, Isocratic, rapid and selective RP-UPLC method was developed for the quantification of Capecitabine in active pharmaceutical ingredients (API’S) using a simple mobile phase of solution A (5.0g of sodium dodecyl sulfate and 2.0 g of monobasic sodium phosphate were dissolved in one liter of water and adjusted the pH to 3.8 with 10% phosphoric acid) and solution B acetonitrile in the ratio of 65:35 at a flow rate of 0.50 mL/min. The chromatographic separation was achieved on a Poroshell C18 column of dimension 4.6 X 50 mm, 2.7µm. The column and sample compartment temperatures were maintained at ambient. UV detector was monitored at 303nm. The retention time (RT) of Eszopiclone was about 8.4min at an overall runtime of 12min. The developed method was validated as per the requirements of ICH guidelines. Finally a comparison of the method was done against conventional HPLC. The developed method was superior with respect to analysis time, efficiency and sensitivity. The runtime of Eszopiclone in conventional hplc method was about 60.0min. Compare to HPLC method the developed method is cost effective and more rugged. The method can be used for routine analysis of assay in Quality Control laboratory on regular basis.

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