Development and Validation of a Stability Indicating RP-HPLC Method for Estimation of Etizolam in Tablet Dosage Form

Abstract

A simple, precise, and sensitive stability indicating liquid chromatographic method was developed and validated for Etizolam in tablets. An isocratic RP-HPLC method was developed for Etizolam on a C18 Agilent (150 x 4.6 mm x 3.5µm) column using a mobile phase consisting of acetonitrile and triethylamine solution, pH 3.2 (50:50, v/v) at a flow rate of 1.0 mL/min. The chromatographic peaks for Etizolam were eluted at 3.21 ± 0.24 min and the detection was carried out at 254 nm. The method obeyed linearity in the range of 0.5 - 100 µg/mL (r2=0.999). The method gave repeated results as observed from the % RSD (< 2.0) indicating the precision. The mean recovery obtained in the present method was found to be 98.58 ± 0.32%. The drug was subjected to a variety of stress environments and was highly sensitive to acid, base and oxidation conditions. The method was validated as per ICH guidelines in terms of specificity, accuracy, precision, LOD, LOQ and robustness. This method can be used for quantification of Etizolam in tablet dosage form without any interference from excipients.