RP-HPLC Method Development and Validation for Cariprazine Hydrochloride and its Forced Degradation Study

Background: Cariprazine hydrochloride is antipsychotic drug used to treat schizophrenia. A simple and accurate reverse phase HPLC method for cariprazine HCL was developed and validated.Method: The chromatographic separation was carried out by injecting (10 µL) sample to the HPLC system connected to Agilent Zorbax Bonus – RP (250 mm × 4.6 mm, 5 µm) operating at 1 mL/min flow rate, column temperature 30°C and detection was at 248 nm.Result: The method provided linearity range from 80 to 120 µg/mL with LOD value 4.48 µg/mL and LOQ of 13.56 µg/mL. The method was validated for other parameters like specificity, solution stability, precision and robustness. Results found were within range and found to be satisfactory. Potential degradation of the cariprazine HCL when exposed to base was 53.32%.Conclusion: The developed method has significant applicability for quantification of cariprazine HLC in different dosage formulations.