A High-Performance Liquid Chromatographic Method for Dissolution Testing of Lurasidone Tablets

A simple, rapid, selective, and reproducible HPLC method for Lurasidone Hydrochloride tablet release estimation has been developed and validated. An Agilent, X-Bridge column C18,150*4.6 mm, 3.5m was used to produce a symmetrical peak form at a regulated column temperature of 25°C with a flow rate of 1.5 mL/min, a mobile phase component of A and B in the ratio of 30:70, a run time of 14 minutes, and an isocratic elution. Mobile phase A is 0.2% ammonia in water with a pH of 8.5, and mobile phase B is 98:2 acetonitrile and water. At 232 nm, 25 μL sample solutions were injected. A two-stage acid-buffer dissolution condition simulated GI transit pH shift was used. The acid stage consisted of 500 mL of 0.1N HCl solution in each vessel USP apparatus-2 at 75 rpm for 60 minutes, followed by 500 mL of concentrated buffer media in each vessel and continued dissolution with the same parameters. Dissolution method suitability, specificity, precision, accuracy, linearity, robustness, and solution stability have been verified. From the validation data, a set of system appropriateness requirements for the approach have been created. The minimum level at which the technique was found to be sensitive to LH was1.2 µg/mL, 1.2 µg/mL to 18.0 µg/mL was the range for the method’s development, which was based on accuracy and linearity tests. The solutions passed a 24-hour stability test while being stored at room temperature.