Stability Indicating RP-HPLC Method Development & Validation for Lumateperone Tosylate Drug in Bulk & It’s Capsule Dosage Form

Abstract

A stability-indicating reverse phase high performance liquid chromatography method was developed and validated for Lumateperone tosylate. The wavelength selected for quantitation was 227 nm. The method has been validated for linearity, accuracy, precision, robustness, limit of detection and limit of quantitation. Linearity was observed in the concentration range of 2-10 μg/ml. For RP-HPLC, the separation was achieved by column Phenomenex C18 (250 mm X 4.6mm ID, particle size 5 μm). At a flow rate 1.00 ml/min using the mobile phase Methanol:0.1% OPA in water (45:55%V/V) at a wavelength 227nm with a chromatographic  run time 10 min, The retention time Lumateperone tosylate were found to be 9.28 min. respectively. During force degradation, drug product was exposed to hydrolysis (acid and base hydrolysis), H₂O₂, thermal degradation and photo degradation. The % degradation was found to be 10 to 20% for dug in the given condition. The method specifically estimates the drug in presence of all the degradants generated during forced degradation study. The developed methods were simple, specific and economic which can be used for estimation of Lumateperone tosylate in bulk & its pharmaceutical dosage form.