RP-HPLC Method Development and Validation for the Estimation of Chlordiazepoxide in Novel Excipient Containing Formulations

Abstract

An effort has been made to establish a simple and exact reverse-phase HPLC technique for the analysis of Chlordiazepoxide in bulk medication and formulations. A Phenomenex Luna C18 stationary phase (250 4.6 mm, 5) and dipotassium hydrogen phosphate anhydrous buffer (pH 6.8) and acetonitrile in an isocratic mode were employed in this method's present development. Following the ICH recommendations, many aspects such as linearity range, system applicability and accuracy and precision were examined. The LOD and LOQ were also evaluated. Robustness and solution stability were also examined. Chlordiazepoxide concentrations in a new formulation comprising an excipient were successfully measured using the newly designed and validated technique. When using the approach, the recovery rate was determined to be between 99.00 percent and 101.00 percent. Detection and quantification of Chlordiazepoxide in pharmaceutical formulations were shown to be possible using this method (99.7 percent). Methods for rapid screening of Chlordiazepoxide in bulk pharmaceuticals and formulations were developed using an RP-HPLC technology that is both linear and robust.