PHARMANEST : AN INTERNATIONAL JOURNAL OF ADVANCES IN PHARMACEUTICAL SCIENCES - Volume 4, Issue 6, November - December 2013

Pages: 1162-1176

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A NOVEL VALIDATED RP-HPLC METHOD FOR THE DETERMINATION OF ESCITALOPRAM OXALATE IN BULK AND PHARMACEUTICAL TABLET DOSAGE FORMS

Author: P.RAVISANKAR*, B. KRISHNA SWAPNA, K.V.S. SANTOSH KUMAR, CH.DEVADASU, P.SRINIVASA BABU, G.DEVALA RAO

Category: Pharmaceutical Sciences

Abstract:

An accurate, novel, highly sensitive, precise, simple, efficient and reproducible, isocratic Reversed Phase-High Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the quantitative determination of Escitalopram oxalate in pharmaceutical tablet dosage forms. RPHPLC method was developed by using Welchrom C18 Column (4.6 X 250mm, 5µm), Shimadzu LC20AT Prominence Liquid Chromatograph. The mobile phase composed of Phosphate buffer (pH-7.48, adjusted with triethylamine): acetonitrile (50:50 v/v). The flow rate was set to 1.0 mL/min with the responses measured at 240 nm using Shimadzu SPD-20A Prominence UV-Vis detector. The retention time of Escitalopram oxalate was found to be 5.43 min. Linearity was established for Escitalopram oxalate in the range of 2-10 µg/mL with correlation coefficient 0.999. The percentage recovery was found to be 99.14% to 101.3%. Validation parameters such as specificity, linearity, precision, accuracy, robustness, limit of detection (LOD) and limit of quantitation (LOQ) were evaluated for the method according to the International Conference on Harmonization (ICH) Q2 R1 guidelines. The developed method was successfully applied for the quantitative analysis of commercially available dosage form.

Keywords: Escitalopram oxalate, Isocratic RP-HPLC, UV-Vis detector, Method Validation.