Abstract

DEVELOPMENT AND VALIDATION OF FIRST ORDER DERIVATIVE SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS ESTIMATION OF ESCITALOPRAM OXALATE AND CLONAZEPAM IN TABLET DOSAGE FORM

Satish A. Patel and Riya N. Patel*

ABSTRACT

The present manuscript describes simple, sensitive rapid and economical first order derivative method for simultaneous estimation of Clonazepam and Escitalopram oxalate in tablet dosage form. The overlain derivative spectra of Clonazepam and Escitalopram oxalate in methanol shows the zero-crossing point at 244 nm and 223 nm for Clonazepam and Escitalopram oxalate, respectively. Hence these two analytical wavelengths were used for simultaneous determination of Escitalopram oxalate and Clonazepam, respectively from tablet dosage form. Beer’s law was obeyed in the concentration range of 2 to 20 μg/ml for Clonazepam and 4 to 40 μg/ml for Escitalopram oxalate. The method was validated as per ICH guideline in terms of linearity, accuracy, precision (repeatability, intraday, interday), limit of detection and limit of quantification. All the validation parameters were found to be within acceptable limits. The method is found to be simple, sensitive, rapid, cost effective, accurate, and precise. The assay results are in good agreement with label claim of both drugs, so the developed and validated derivative spectrophotometric method can be used for the quality control as well as routine analysis of both drugs from pharmaceutical tablet dosage form.

Keywords: Clonazepam, Escitalopram Oxalate, First order derivative, Zero-crossing point, Spectrophotometric, Validation.