Abstract

DEVELOPMENT AND VALIDATION OF A METHOD FOR QUALITATIVE & QUANTITATIVE ANALYSIS OF AMITRIPTYLINE USING UV VISIBLE SPECTROPHOTOMETER

Shikha Sharma, Gurleen Kaur, Surender Singh Sehrawat*

Abstract

Amitriptyline is a tricyclic antidepressant, anticholinergic drug and has sedative properties, which is mainly used for treating depression. On overuse of amitriptyline, dizziness, headache, weight gain, delirium, disorientation, anxiety, and agitation are some of the side effects. This drug has many side effects and causes high toxicity in case of overdose. Deaths due to toxicity of amitriptyline are relatively common. It raises the risk of suicidal thinking and behavior in people of all age groups. The adverse effects increase the drug’s medico-legal importance and hence it becomes necessary to analyze this drug for identification purpose in the field of forensic analytical toxicology. Routinely, High Performance Liquid Chromatography, Gas Chromatography, Gas Chromatography-Mass-Spectroscopy and Liquid Chromatography- Mass Spectroscopy are used for analysis of amitriptyline. These techniques are not only costly but also require more sophisticated instruments which are not available in each laboratory. In this study, analysis was performed by UV-Visible spectrophotometer in pure formulation on the basis of absorbance of UV absorption by target compound. A simple, precise and highly cost efficient UV spectroscopic method has been formed for the analysis of amitriptyline. The technique was validated according to the United States Pharmacopoeia (USP) guidelines, which looked at the technique's range, linearity, accuracy, recovery, precision, and sensitivity. In Distilled Water: Methanol (9:1)v/v, amitriptyline had a maximum wavelength of absorbance of 240 nm and obeyed linearity or Beer-law Lambert's in the concentration range of 5-25 g/ml. The regression coefficient (R2) was determined to be 0.997. 3.1910 g/ml and 9.6697 g/ml were determined to be the Limits of Detection (LOD) and Quantification (LOQ), respectively. The new approach was repeatable, cost-effective, and non-destructive, allowing it to be used effectively for the accurate and precise analysis of amitriptyline.

Keywords: Method Development, USP validation, Amitriptyline, UV-Vis spectroscopy, Linearity.