Degradation studies on lurasidone hydrochloride using validated reverse phase HPLC and LC-MS/MS

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis
• Chromatography

Background:

• Lurasidone hydrochloride is an antipsychotic drug.
• Ensuring the stability and quality of pharmaceutical products is critical.
• Developing robust analytical methods is essential for drug quality control.

Purpose of the Study:

• To develop and validate a stability-indicating RP-HPLC method for Lurasidone hydrochloride.
• To assess the drug's stability under various stress conditions.
• To utilize LC-MS/MS for identifying degradation products and intermediates.

Main Methods:

• A Binary Gradient HPLC System with a PDA detector and C18 column was employed.
• LC-MS/MS analysis was performed using a Shimadzu 8040 series triple quadrupole mass analyzer.
• Forced degradation studies were conducted under acidic, alkaline, oxidative, neutral, and photolytic conditions.

Main Results:

• The method demonstrated linearity (r²=0.999) within 10-50 μg/mL, with LOD of 0.091 μg/mL and LOQ of 0.275 μg/mL.
• Lurasidone hydrochloride showed increased susceptibility to alkali hydrolysis.
• Degradation products were identified using LC-MS, with specific fragmentation peaks observed.

Conclusions:

• The developed RP-HPLC method is stability-indicating and suitable for routine quality control of Lurasidone hydrochloride.
• The method effectively evaluates drug stability and aids in identifying potential drug intermediates.
• LC-MS/MS analysis provides valuable data for understanding drug degradation pathways.