ARCHIVES
VOL. 11, ISSUE 3 (2026)
Development and validation of an RP-UPLC method for the estimation of Cariprazine Hydrochloride in bulk drug and pharmaceutical dosage form
Authors
Narasimha Rao B V, Prasada Rao M, Gayathri Devi K, Udaya Krishna Veni A, D Munnira
Abstract
Cariprazine hydrochloride, an atypical antipsychotic used in the management of schizophrenia, bipolar I disorder, and as adjunctive therapy for major depressive disorder, lacked a simple, validated UPLC method for its routine estimation in both bulk drug and pharmaceutical dosage form. The present study aimed to develop and validate a UPLC method for Cariprazine hydrochloride in accordance with ICH Q2(R1) guidelines. Chromatographic separation was achieved under optimized UPLC conditions, giving a sharp, symmetric Cariprazine hydrochloride peak at a retention time of 3.523 min, with 7431 theoretical plates and a tailing factor of 1.09. The method was linear over 10–60 µg/mL, with a regression equation of y = 2537.14x + 48889.53 and a correlation coefficient (r²) of 0.99988. The LOD and LOQ, calculated from the linearity regression, were found to be 0.765 µg/mL and 2.319 µg/mL respectively, confirming adequate sensitivity. The developed UPLC method was validated for precision (system %RSD 0.71%, method %RSD 0.88%), accuracy (recovery 98.33–99.55%), ruggedness (%RSD 0.71%), and robustness (percentage change 0.38–0.60% under deliberate variation of mobile phase and flow rate), with all parameters within ICH-acceptable limits. The validated UPLC method was successfully applied to the estimation of Cariprazine hydrochloride in bulk drug (99.88% purity) and the marketed capsule formulation Caripriza (99.91% of the 3 mg label claim), confirming its applicability across both matrices. The developed UPLC method is simple, rapid, sensitive, accurate, precise, rugged, and robust, and represents a useful addition to existing analytical methodology for the routine quality control of Cariprazine hydrochloride.
Download
Pages:42-46
How to cite this article:
Narasimha Rao B V, Prasada Rao M, Gayathri Devi K, Udaya Krishna Veni A, D Munnira "Development and validation of an RP-UPLC method for the estimation of Cariprazine Hydrochloride in bulk drug and pharmaceutical dosage form". International Journal of Pharmaceutical Science and Research, Vol 11, Issue 3, 2026, Pages 42-46
Pdf, Certificate, Cover Page, Index Page, Editorial Page, Accept Letter
Please enter the email address corresponding to this article submission.

