In the present study an economical, simple, precise, rapid, sensitive and accurate and reproducible Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method has been developed and validated for Lurasidone Hydrochloride. The chromatographic separation was carried out by using reverse phase stainless steel column of (4.6 mm × 25 cm) Purospher® STAR Hibar® C18 column with 5 µm (particles packing) held at 25°C. The mobile phase consisted of acetonitrile: Phosphate buffer (0.01M) (70:30 v/v), with a flow rate of 1.0 ml/ min and UV detection at 230 nm and injection volume 20 µL was maintained. The retention time was found to be 4.231 min. The different analytical performance parameters such as linearity, accuracy, precision and sensitivity (limit of detection and limit of quantitation) were determined according to International Conference on Harmonization ICH guidelines. The linearity was observed in the range of 10-100 µg/mL with correlation coefficient, r = 0.9963. The proposed method is rapid, cost-effective and can be used as a quality-control tool for routine quantitative analysis of Lurasidone HCl.
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