METHOD DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ESCITALOPRAM OXALATE AND ETIZOLAM IN BULK AND ITS PHARMACEUTICAL FORMULATIONS

Author(s): Kalpana Nekkala, V Shanmukha Kumar J, D Ramachandran, Ganji Ramanaiah and Ganta Srinivas

Abstract

A new rapid, precise and sensitive reverse phase high performance liquid chromatographic (RP�?¢�?�?��?HPLC) method has been developed and validated for the estimation of Escitalopram and Etizolam simultaneously in combined dosage form. The two components Escitalopram and Etizolam were well resolved on an isocratic method, C18 column, utilizing a mobile phase composition of acetonitrile: methanol: 0.02M ammonium acetate buffer (30:20:50), v/v, pH 4.5) at a flow rate of 1.0 mL/min with UV detection at 227 nm. The retention time of Escitalopram and Etizolam were 2.3 min and 5.7 min respectively. The developed method was validated for specificity, linearity, precision, accuracy, limit of detection (LOD), limit of quantification (LOQ) and robustness as per ICH guidelines. Linearity for Escitalopram and Etizolam were found in the range of 30�?¢�?�?��?70 μg/ml and 3.0�?¢�?�?��?7.0 μg/ml, respectively. The percentage recoveries for Escitalopram and Etizolam ranged from 98.5�?¢�?�?��? 101.2 % and 98.4�?¢�?�?��?100.8 %, respectively. The proposed method could be used for routine analysis of Escitalopram and Etizolam in their combined dosage forms.

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