UV-Visible First Order Derivative Spectrophotometric Method Development and Validation for Simultaneous Estimation of Amitriptyline Hydrochloride and Chlordiazepoxide in Tablet Dosage Form

Abstract

A simple, precise, fast, accurate and sensitive UV-visible first order derivative spectrophotometric method was developed and validated for amitriptyline and chlordiazepoxide estimation in pure and tablet dosage form. The method involved determination of amitriptyline and chlordiazepoxide using first derivative spectrophotometric technique at 219 nm and 239 nm over the concentration ranges of 5-17 μg/mL and 1-7 μg/mL. Mean recoveries were found to be about 98.33 ± 0.45 % w/w for amitriptyline and 99.75 ± 1.16 % w/w for chlordiazepoxide. The coefficient (r²) were 0.9998 for amitriptyline and 0.9997 for chlordiazepoxide, respectively. The limit of detection and limit of quantification were found to be 131 and 398 ng/mL, respectively for amitriptyline and 26 and 79 ng/mL, respectively for chlordiazepoxide. The assay percentage of the marketed formulation calculated were 99.87 ± 0.03 % w/w for amitriptyline and 98.81 ± 1.04 % w/w for chlordiazepoxide, respectively. This study provides a validated UV spectrophotometric method by using a first order derivative method. This validated method was carried out with respect to the parameters such as linearity, specificity, stability, accuracy, precision, limit of quantification and limit of detection in the light of internationally accepted ICH guidelines.