Development and Validation of Three Novel UV Spectrophotometric Methods for Determination of Newly Discovered Combination for the Treatment of Anxiety and Comparison Using Anova

Abstract

Paroxetine HCl and Etizolam is a newly approved combination which is used for treating anxiety. It is necessary to develop a method to estimate both drugs in combined dosage form. For simultaneous estimation of Paroxetine HCl and Etizolam three simple, precise and sensitive UV spectrophotometric methods were developed in the present work. Method 1 first order derivative methods, ZCP selected were 241.50 nm for Etizolam and 256.50 nm for Paroxetine HCl. Method 2 is absorbance correction method, 243 n and 295 nm were used to estimate the both the drugs. Method 3 is dual wavelength method, 230 nm and 250 nm were selected for estimation of Paroxetine HCl and 221.50 nm and 288 nm were selected for estimation of Etizolam. Calibration curve of Paroxetine HCl and Etizolam had shown linearity over the concentration range of 25-150 µg/ml and 1-6 µg/ml, respectively, in all three methods. All the three methods were validated as per ICH guidelines and all the results were found within limits. By using ANOVA three methods were compared and it was found that F_cal is less than F_tab which indicates that there was no significant difference observed between the assays obtained by all three methods. All the three proposed methods can be used for its intended purpose because they are highly sensitive, accurate and precise.