DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC AND RP HPLC METHOD FOR THE ESTIMATION OF ESZOPICLONE BULK AND TABLETS

Abstract

Objective: Objective of the present analytical research work was to develop and validate Spectrophotometric method and Reverse Phase High Performance Liquid Chromatographic method (RP-HPLC Method) for the Eszopiclone bulk and tablets dosage form. Methods: A spectrophotometric method and a RP-HPLC method have been developed and validated for estimation of ESZ in pharmaceutical oral dosage form. Method A (RP-HPLC Method): The RP-HPLC Method for Eszopiclone was developed using Shimadzu HPLC, LC-10, temperature maintained 25 0 C, phenorex Gemini C18 (250 mm 4.60 mm 5?m), as stationary particle, isocratic mode. MeOH: Water (80:20v/v) as mobile phase. Mobile phase was maintained at a flow rate of 1.0 ml/min and detection was carried out at 305 nm. Method B (UV SPECTROMETRY Method): The stock and working standard solutions of the drugs were prepared in methanol. Standard solutions were scanned over the range of 400-200 nm in spectrum mode of spectrophotometer at medium scanning speed using UV spectrophotometer 2450, SHIMADZU. The maximum absorbance for Eszopiclone was found at 305 nm. Both the methods were validated in accordance with ICH guidelines Results: Eszopiclone was found to be linear in the concentration range of 4 - 24 ?g/ml for spectrophotometric method and 5-30 ?g/ml for RP-HPLC method. Retention time was found to be 5.38 min for Eszopiclone. The amount of Eszopiclone in marketed formulation by spectrophotometric method was found to be 100.02 %, the amount of Eszopiclone in marketed formulation by RP-HPLC method was found to be 100.03 %. Interpretation and Conclusion: Results of assay and validation study were found to be satisfactory. So, the methods can be successfully applied for the routine analysis of Eszopiclone.