Development and validation of a New HPLC Method for Determination of Clorazepate Dipotassium in Capsule Formulations

  • Safwan Ashour


A simple accurate and rapid high performance liquid chromatographic method has been developed and applied for determination of clorazepate dipotassium in capsules. Rosuvastatin calcium was used as internal standard. The determination was performed on Supelcosil C8 DB column 250×4.6mm i.d. 5µm particle size at 25 °C using a mobile phase composed of MeOH and 0.1 M HCOOH pH 2.16 67:33 v/v pumped at a flow rate 1.0 mL min-1. The photodiode array detector was operated at 245 nm. The retention times for rosuvastatin and clorazepate were about 5.05 and 6.85 min respectively. Results of assay were statistically evaluated for its accuracy and precision. Linearity range was 2.15–400.0 µg mL-1. The limits of quantification and detection were 1.31 and 0.39 µg mL-1 respectively. The intra-day precision results expressed by relative standard deviation values were lower than 2.35. The validated method has been successfully applied to the analysis of clorazepate dipotassium in capsules with no interference from the excipients.