DEVELOPMENT OF A VALIDATED FORCED DEGRADATION STUDY FOR CHARACTERIZATION OF CICLESONIDE DEGRADANTS USING LC-MS
AbstractThe stressed degradation study of Ciclesonide was conducted using various conditions, including acid, base, photolytic, thermal, and oxidative degradation. LC-MS was employed to characterize the degradants formed during these stress conditions. To assess the stability of Ciclesonide under stress, the study followed the guidelines outlined in ICH Q1A (R2). During the analysis, a C18 column (250mm x 4.6ID, 5 Micron) was utilized with a mobile phase of methanol: water (95:05) pH 3, adjusted with Ortho phosphoric acid, flowing at a rate of 0.9 ml/min. The analysis was performed using a PDA detector at an ambient temperature, with a retention time of 7.5 minutes for the drug. UV detection at 225nm was used for quantification. The results revealed the formation of a significant amount of a new compound under the stress conditions of acid, base, photolytic, and thermal degradation. LC-MS data confirmed the presence of stressed impurities of ciclesonide. This method was successfully applied in quality control laboratories for the determination of Ciclesonide, along with its decomposition products.
Article Information
33
900-908
762 KB
253
English
IJPSR
Pallavi V. Duse * and Kamalkishor G. Baheti
Department of Pharmaceutical Chemistry, Y.B. Chavan College of Pharmacy, Rauza Bagh, Aurangabad, Maharashtra, India.
palaskarpallavi@gmail.com
05 August 2023
22 October 2023
30 December 2023
10.13040/IJPSR.0975-8232.15(3).900-08
01 March 2024
Download