TITLE-SPECTRO SCOPIC DETERMINATION OF AZIDE CONTENT IN IRBISARTAN DRUG SUBSTANCE

Abstract

Objective:

The synthesis of drugs often involves various reagents and intermediates, and azides are one such class of compounds that are commonly used in organic synthesis due to their ability to undergo nucleophilic displacement reactions. However, azides can also be potentially genotoxic, posing a risk to drug safety. Therefore, it is important to monitor and quantify azide levels in drug substances to ensure they remain within acceptable limits.

Irbisartan (also known as irbesartan) is a drug used to treat high blood pressure and diabetic nephropathy. The synthesis of irbesartan involve azide-containing intermediates, which necessitates the development of a method for detecting and quantifying any residual azides in the final drug substance. A UV method was developed to identify azide content in Irbisartan.

Methods:

This analytical method, developed for the estimation of azide by adding of ferric ammonium sulfate, gives a characteristic color at neutral pH showing an absorbance maximum of 458nm.

Results and conclusion:

Linearity studies indicated that estimation of azide between 6µg/g – 42µg/g was found to be linear with regression equation of y=0.004x+0.034(R²0.998). This method was developed was validated for accuracy, precision, Linearity, Limit of detection (LOD), Limit of quantification (LOQ) studies. The relative standard deviation (% RSD) intraday and inter-day precisions are 0.86 and 0.75 respectively. In accuracy studies, recovery was found in the range of 98-101%. The Limit of detection (LOD) and Limit of quantification (LOQ) were found to be 1.96µg/g and 5.93µg/g respectively. The above analytical parameters indicated that the developed UV spectrophotometric method of azide content in was developed for the Irbisartan drug substance. This method is simple, Accurate & Reproducible, less expensive method.

Azide compounds have the potential to generate genotoxic impurities because of their ability to decompose and produce reactive nitrogen species. These species can damage cellular components, increasing the risk of genotoxic effects.