UV Spectrophotometric Method Development and Validation for Quantitative Analysis of Cariprazine Hydrochloride

Cariprazine is a novel antipsychotic drugs which is commonly prescribed for the management of schizophrenia and bipolar disorder. This study is designed to develop and validate a UV spectrophotometric method for quantitative estimation of Cariprazine HCl in compliance with ICH guidelines. The method was validated for various key parameters, like linearity, precision, repeatability, limit of detection (LOD), limit of quantification (LOQ), accuracy, robustness, and ruggedness. Cariprazine HCl exhibited maximum absorbance in water at 244 nm. The concentration rage between 10-70 μg/mL depicted, with a regression coefficient (r²) of 0.999. The LOD and LOQ were estimated as 5.823 μg/mL and 17.64 μg/mL, correspondingly. Intraday & interday studies showed relative standard deviations below 2%, validating the method’s precision. Recovery studies were conducted to confirm accuracy, yielding results between 100 to 102%. The percentage of the drug estimated in the pharmaceutical marketed formulation was 100.1%, demonstrating excellent agreement with the label claim. Therefore, it can be concluded that, the developed method is reliable, demonstrating precision, accuracy, and repeatability, making it well-suited for day-to-day analysis of Cariprazine HCl in bulk and pharmaceutical formulations.