Development of RP-HPLC based analytical method for determination of cariprazine hydrochloride in bulk drug and pharmaceutical dosage form using box-behnken statistical design

Abstract

A robust as well as precise technique aimed at determining the concentration of Cariprazine in bulk drugs along with formulations using RP-HPLC has been developed. The robustness study was optimized using Box Behnken statistical design. Separation was achieved using an Agilent 1260 Infinity II HPLC with an Agilent Zorbax Bonus RP column, as well as the mobile phase contained of methanol and 0.1% trifluoroacetic acid buffer (52.5:47.5) at a flow rate of 1 ml/min. The wavelength was set at 248 nm, and the method had an overall running period of 8 minutes, with the Cariprazine peak retention time at 3.83 min. The method exhibited linearity and accuracy for concentrations ranging from 80 to 120 μg/ml, with an R² of 0.999 and accuracy RSD of 0.2%, 0.13%, and 0.05% for 80%, 100%, and 120%, respectively. Stress stability testing under basic conditions revealed 53.32% degradation. The technique’s limit of detection (LOD) and limit of quantification (LOQ) were very low, at 44.80 ng/ml and 135.60 ng/ml, correspondingly. These findings suggest that this method may be helpful during regular quality control evaluation of Cariprazine Hydrochloride in a variety of pharmaceutical formulations.

GRAPHICAL ABSTRACT

Keywords:

• Cariprazine Hydrochloride
• RP-HPLC
• Validation
• Schizophrenia
• Method development