JOURNAL 2338


Journal of Chemical Metrology
VOLUME & ISSUE
Available Online: May 01,2022
PAGES
p.1 - 14
DOI ADDRESS
http://doi.org/10.25135/jcm.68.2201.2338
(DOI number will be activated after the manuscript has been available in an issue.)
STATISTICS
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AUTHORS
  • Pallekona Sushma
  • A. Krishnamanjari Pawar
PDF OF ARTICLE

GRAPHICAL ABSTRACT


ABSTRACT


The Present work aims at the determination of degradation products by a developing an efficient method which was achieved by utilizing Waters C18 150x4.6mm, 3.35-micron column with flow rate of 1mL/min in an innovative, simple, and an accurate high-performance liquid chromatographic method. The mobile phase of methanol and 0.1% orthophosphoric acid in proportion of 50:50 (% v/v) ratio was employed at a wavelength of 216 nm. The recommended approach demonstrated good linearity in the Cariprazine HCl concentration range of 5 µg/mL to 75 µg/mL. Studies on precision and recovery have shown accuracy rates ranging from 98 to 102%. All robustness conditions have an RSD of less than 2%. Solvent stability is maintained over 24 hours even when subjected to high stress levels. According to ICH guidelines, method validation is performed, and the parameters investigated include precision and accuracy as well as specificity and stability along with robustness, linearity, the limit of detection and the limit of quantification as well as the limit of detection. The ultimate composition of degradation products was determined using Tandem Mass Spectrometry with Liquid Chromatography and all the degradant are formed at various stress conditions were successfully characterized and the possible pathways were demonstrated.

KEYWORDS
  • Degradant
  • ICH Guidelines
  • LCMS
  • RP-HPLC
  • cariprazine HCl

SUPPORTING INFORMATION


Supporting Information
Download File 68-JCM-2201-2338-SI.pdf (677.85 KB)