Quantification and Validation of Eszopiclone by Liquid Chromatographic Method Through Isocratic Separation

Abstract

Introduction: A reverse phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for the estimation of Eszopiclone in pharmaceutical dosage forms.

Objectives: The chromatographic separation of Eszopiclone was achieved on a Thermo Hypersil BDS C18 column (250mm×4.6 mm, 5µm particle size), Agilent LC1220 HPLC system with UV detection (VWD detector) at 315nm.

Methods: The optimized mobile phase was consisted of Methanol: Water (PH adjusted to 2.5 with orthophosphoric acid) (40:60 v/v). The flow rate was 1ml / min and effluents were monitored at 315nm. Chromatogram showed the main peak at a retention time of 2.057min. The method was validated for linearity, accuracy, precision, and limit of detection, limit of quantitation, robustness and ruggedness.

Results: The linearity was found in the concentration range of 25-150µg/ml. The Correlation coefficient was 0.999. The regression equation was found to be Y = 71703x+16358. The limit of detection and limit of quantitation for estimation of Eszopiclone was found to be 0.05 µg / ml and 0.16 µg / ml respectively.

Conclusions: Recovery of Eszopiclone was found to be in the range of 99.9-100.01%. Proposed method was successfully applied for the quantitative determination of Eszopiclone in pharmaceutical dosage forms as per ICH guidelines.