• Josef Yakin
• Mrs. Akkamma H.G
• Dr.Chandanam Sreedhar
• T Srinivas Rao
• Ashmita Singh

A simple and reproducible method was developed for Lurasidone HCL by Reverse Phase High Performance Liquid Chromatography (RP-HPLC). Lurasidone HCL was separated on Agilent Extended C18 column (5μm, 4.6x150mm) and a mobile phase containing Acetonitrile: Formic acid buffer 0.1% (pH adjusted to 2.8 using triethylamine) in the ratio of 50:50 v/v was used for the separation and quantification. The flow rate was 1.0 mL/min. The retention times were found to be 2.33±0.03 minutes. The developed method was validated according to ICH guidelines with different parameters such as Linearity, Precision, Accuracy, Robustness, Limit of detection (LOD), Limit of quantification (LOQ). The standard curve was linear over a working range of 10-60 µg/ml and gave an average correlation factor 0.996 for Lurasidone HCL. The Limit of detection and Limit of quantification was found to be 2.1µg/ml and 8.5µg/ml respectively of Lurasidone HCL. The RSD values for accuracy and precision studies obtained were less than 2% which revealed that developed method was accurate and precise.

Lurasidone HCL, RP-HPLC, Validation, ICH Guidelines, Linearity, Accuracy

"New Analytical Method Development and Validation for Estimation of Lurasidone Hydrochloride by RP-HPLC Method in Bulk and Pharmaceutical Dosage Form", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.6, Issue 3, page no.553-561, March-2019, Available :http://www.jetir.org/papers/JETIR1903D85.pdf

"New Analytical Method Development and Validation for Estimation of Lurasidone Hydrochloride by RP-HPLC Method in Bulk and Pharmaceutical Dosage Form", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.6, Issue 3, page no. pp553-561, March-2019, Available at : http://www.jetir.org/papers/JETIR1903D85.pdf