Volume 14

January-March 2022​

Method development and validation of cariprazine hydrochloride in bulk by UV ‎spectrophotometric method​

Pallavi Chiprikar, Vinayak Mastiholimath

Abstract:
The goal is to develop and validate a simple, sensitive, precise, fast, and cost-effective method for estimating Cariprazine Hydrochloride in bulk in compliance with ICH guidelines. Linearity, Precision, Repeatability, Limit of Detection (LOD), Limit of Quantification (LOQ), Accuracy, Robustness, and Ruggedness of a simple double beam UV Spectrophotometric method have all been developed and validated. The absorbance of cariprazine hydrochoride in methanol is 252 nm. The LOD and LOQ were determined to be 1.63g/ml and 4.94g/ml, respectively, in the concentration range of 10-50 g/ml, supporting Beer’s law. The proposed approach is precise, accurate, and repeatable, and it may be used to analyse Cariprazine hydrochloride in bulk on a routine basis.

Keywords: Cariprazine Hydrochloride, Method Development, Validation, Ultraviolet Spectroscopy.