Method Development and Validation for the Simultaneous Estimation of Clonazepam and Paroxetine in Combined Dosage Form using FT-IR

Abstract

An analytical methodology was developed for the simultaneous estimation of Clonazepam and Paroxetine in combined dosage form. The method involves the use of N-naphthyl ethylene diamine (NED) as reagent. In this method the absorbance was measured at 535nm for Clonazepam and 398nm for Paroxetine. Linearity was observed in the range of 1–9μg/ml for Clonazepam 25–225μg/ml. The regression equation for the calibration data was y=0.001x + 0.653 with correlation coefficient of 0.99 for Clonazepam and y=0.047x + 0.130 with correlation coefficient of 0.981for Paroxetine. The limits of detection were 0.2μg/ml for Clonazepam and 2μg/ml for Paroxetine and the limit of quantitation were 0.6μg/ml and 16μg/ml for Clonazepam and Paroxetine respectively. The precision of the method was good. The values of the relative standard deviation did not exceed 2%. The proposed method was successfully applied for the simultaneous estimation of Clonazepam and Paroxetine in its combined tablet dosage form with good accuracy and precision. All the analytical validation parameters were determined and found in the limit as per ICH guidelines, which indicates the validity of the method. The developed method was found to be precise, accurate, rugged and robust for the simultaneous estimation of Clonazepam and Paroxetine in its combined dosage forms.