Development and Validation of A Rapid and Sensitive HPLC Method for Estimation of Racecadotril

Abstract

: A simple, specific, sensitive and rapid reverse phase high performance liquid chromatographic (HPLC) method for the determination of racecadotril (RCD) was developed and validated. Sample preparation involved simple dissolution, followed by dilution with mobile phase to eliminate any chromatographic solvent effects. RCD was quantitated on a C18 column (4.6 mm i.d. × 300 mm length), using a mobile phase composed of acetonitrile: water (65:35 %v/v) which was delivered at a flow rate of 1.0 mL/min. The method was proven to be linear over a concentration range of 5 to 100 μg/mL with a mean correlation coefficient of 0.9991. The intra-day and inter-day precision (coefficient of variation) were in the range of 0.53% to 0.92% and 0.95% to 1.76%, respectively. The intra-day accuracy (relative error) were in the range of 2.53% to 4.47% and the inter-day accuracy were in the range of 3.11% to 4.92%. The limit of detection (LOD) and the limit of quantification (LOQ) of the developed method were determined to be 0.5 μg/mL and 5 μg/mL, respectively. The developed method was established as a rapid analytical tool as it required short retention time, high precision, sensitivity and small volumes of sample for analysis