Analytical method validation for the simultaneous determination of diazepam in bulk and tablet dosage form

Abstract

This paper describes an UV spectrophotometric validation method for the simultaneous determination of Diazepam. The study aimed to provide practical approaches for determining linearity, range, accuracy, precision, specificity, system suitability and limit of detection, lower limit of quantitation and robustness of this analytical method. All determinations were made in a wavelength of 231 nm in a solvent system of methanol: distilled water (1:1). The method was validated as per ICH guidelines and FDA guidance for industry. Here, obtained linear correlation coefficient was 0.999 and the mean recoveries were ≥98%. Hence, the method was found to be simple, rapid, economic, linear, accurate, precise, robust and reproducible and can be used for routine analysis of Diazepam in bulk and tablet dosage form.