A NEW WAY OF METHOD ESTABLISH AND VALIDATED OF RELATED SUBSTANCE OF GLASDEGIB BY RP-HPLC AND ITS FORCED DEGRADATION STUDYAbstract
A novel, simple, and accurate, high-performance liquid chromatographic method has been a developed with quantitative analysis of Glasdegib using Waters X-Bridge C18 150 × 4.6mm, 3.5µ column with a flow rate of 1ml/min. The buffer containing 0.1% OPA and the mixture of two components like Buffer and Acetonitrile in the ratio of 50: 50 is used as mobile phase. The detection was carried out at 250nm. The proposed method shows good linearity in the concentration range from 25µg/ml to 500µg/ml for Glasdegib. Precision and accuracy study results are in between 98-102%. In entire robustness conditions % RSD is below 2.0%. Degradation has minimum effect in stress conditions, and solutions are stable for 24hrs. Method validation is carried out according to ICH guidelines, and the parameters are precision, accuracy, specificity, stability, robustness, linearity; the limit of detection and limit of quantification are evaluated, and the values are found to be within the acceptable limit. The developed method gave good resolution between Glasdegib and its impurities with a short runtime, high efficiency, and complies with modified SST specifications of USP. The result of Glasdegib being subjected to different stress conditions led to the fact that it was stable during the thermal condition. It degraded extensively under UV, Thermal and Peroxide conditions.
P. Satyanarayana, S. Bajivali, M. Usharani and S. Mohan *
Department of Chemistry, Bapatla Engineering College, Bapatla, Andhra Pradesh, India.
17 March 2020
15 June 2020
28 June 2020
01 March 2021