ACCELERATED STABILITY STUDY OF ARSENAZO III USED FOR DETECTION OF CALCIUM FROM BIOLOGICAL SYSTEM THROUGH UV-SPECTROPHOTOMETER, BIOCHEMISTRY ANALYZER, PH METER, HPLC AND HPTLCAbstract
Objective: Stability of In-vitro Diagnostics (IVDs) reagents was performed to check its quality standards, performance, and linearity. IVDs like Calcium reagent containing Arsenazo III were studied by Accelerated stability studies by considering temperature, pH, and light parameters. Materials and Methods: Stability data were obtained by using different instruments like UV spectrophotometer, Biochemistry analyzer, pH meter, HPLC, and HPTLC. This gives information about the degradation that occurred during storage, transportation, etc. Results: Calcium reagent containing Arsenazo III degrade 90.81% when placed at 42 °C by UV spectrophotometer analysis. The stability conditions’ effect on actual serum concentration was measured by taking reagent performance on a biochemistry analyzer. The linearity of reagents decreases at 42 °C and at normal temperature, linearity does not change. HPLC spectra gave degradation of reagent, which was analyzed by its retention time, peak height, and % area. Arsenazo III produces 91.25% remains undecomposed in 3 months when exposed to light. The shelf life of the calcium reagent was found to be 85.36. HPTLC spectra gave degradation of Arsenazo III, which was analyzed by its retention time, peak height. The reagent, during its stability studies, shows a slight change in its pH. Conclusion: From HPLC and HPTLC analysis, it is confirmed that the degradation occurred in Arsenazo III after exposed to an accelerated stability study.
J. R. Kamble, A. S. Sherikar ⃰ and J. I. Disouza
Department of Quality Assurance, Tatyasaheb Kore College of Pharmacy, Warananagar, Panhala, Kolhapur, Maharashtra, India.
12 February 2020
27 January 2021
18 February 2021
01 March 2021