Development of a validated high-performance liquid chromatographic method for the determination of Lurasidone in pharmaceuticals

Abstract

A new, rapid and simple HPLC method for determination of Lurasidone in its tablets has been developed and validated. Lurasidone and internal standard (Chlorpromazine) was separated on a Zorbax XDB C8 column (4.6 x 50 mm, 3.5 µm particle size) set at 40°C and quantified by ultraviolet detection at 230 nm. The mobile phase was phosphate buffer (pH:3, 20 mM): acetonitrile: methanol (55:10:35, v/v/v) with a flow rate of 1.2 mL/min. Retention times of Chlorpromazine and Lurasidone was 4.73 and 6.89 minutes, respectively. The method was found linear over the concentration range of 0.5-50 µg/mL Lurasidone. Limit of detection and quantification values for Lurasidone was 0.1295 and 0.4317 µg/mL, respectively. The intra-and inter day precisions were less than 2% and the mean recoveries were 100.32%, which indicated that the method was precise and accurate. All other validation parameters were found within acceptable limits. The validated method has been successfully applied for determination of Lurasidone in its tablets.

Bioanalytical liquid chromatography–tandem mass spectrometry method development and validation for quantification of lurasidone in rat plasma using ion pairing agent

“…A reliable and accurate method is critical for PK/toxicokinetic studies and the evaluation of parameters like C max , T max , and area under the curve (AUC). Only a few methods are currently available for determining the concentration of LUR in plasma/serum/blood (Atila Karaca & Yeniceli, 2017; Chae et al, 2012; Katteboina et al, 2016; Koo et al, 2011; Patteet et al, 2014, 2015). A comparative study of published methods (refer to Table 1) indicated that two methods for quantitation of LUR from rat plasma reported by Koo et al (2011) and Chae et al (2012) have longer run time of 4.0 and 8.0 min, respectively.…”