Development and Validation of Stability Indicating Method for Terazosin in Bulk and Pharmaceutical Formulation by UV-Spectrophotometer

Abstract

Terazosin hydrochloride is indicated in the symptomatic relief of benign prostatic hyperplasia and it is also used as an antihypertensive agent. A rapid, simple, specific, and economic UV-spectrophotometric method has been developed to determine the stability indicating method for terazosin using water as a solvent. The absorption spectrum of terazosin showed maximum absorbance at 250 nm and obeyed Beer's law in concentration range 1.5-9 µg/ml. Linear regression of absorbance on concentration gave the equation y=0.1103x+0.0101 with correlation coefficient 0.999. The method developed is validated for parameters like specificity, linearity, range, accuracy, precision, limit of detection (LOD), limit of quantitation (LOQ), robustness as per Q2A specifications of the ICH guidelines. The drug sample was exposed to acid, alkali, and oxidation by hydrogen peroxide, thermal and photolytic conditions to study the forced degradation of the drug. The obtained results proved that this method can be employed for the routine analysis of terazosin in bulk as well as in the commercial formulations.