Submit Manuscript  

Article Details


Degradation Kinetics Study of Anastrozole in Different Conditions by Reverse-Phase High-Performance Liquid Chromatography and Confirmation of its Major Degradation Product by Ultra-Performance Liquid Chromatography with Tandem Mass Spectrometry

[ Vol. 15 , Issue. 3 ]

Author(s):

Linjia Sun, Xiaoyang Sun, Yu Chen, Binjie Wang and Xiaohui Chen*   Pages 217 - 223 ( 7 )

Abstract:


Background: Drug stability is essential in the process of drug production, storage, appliance, and so on. Some drugs’ degradation products may even have a toxic side effect, which can result in safety risks and economic losses. Therefore, it is very imperative to develop a suitable stability indicating an analytical method for anastrozole which could be used for stability testing, routine and in-process quality control analysis or other further studies.

Methods: A reverse-phase high-performance liquid chromatography method was developed and validated for the degradation kinetics study of anastrozole, a selective non-steroid third-generation aromatase inhibitor, which would provide a basis for further studies on anastrozole. The degradation product was confirmed by ultra-performance liquid chromatography with tandem mass spectrometry.

Results: Results showed that the degradation behavior of anastrozole followed first-order kinetics in different temperatures, pH values and oxidation conditions. It was suggested that the degradation behavior of anastrozole was pH-dependent and it’s more stable at lower pH values.

Conclusion: A high performance liquid chromatography method was established and used to determine the residual concentration of anastrozole in this study. It was found that the degradation behavior of anastrozole followed first-order kinetics at different temperatures, pH values and oxidation conditions. According to the results, the degradation of anastrozole was found to be pH-dependent and it is more unstable in alkaline conditions. The information of degradation kinetics will be useful for understanding the chemical stability of anastrozole and provide a reference for the further preparation research and clinical therapy of anastrozole.

Keywords:

Anastrozole, degradation kinetics, kinetic parameters, first-order plot degradation, RP-HPLC, drug stability.

Affiliation:

Department of Pharmaceutical Analysis, School of Pharmacy, Shenyang Pharmaceutical University, Shenyang, Department of Pharmaceutical Analysis, School of Pharmacy, Shenyang Pharmaceutical University, Shenyang, Department of Pharmaceutical Analysis, School of Pharmacy, Shenyang Pharmaceutical University, Shenyang, Department of Pharmaceutical Analysis, School of Pharmacy, Shenyang Pharmaceutical University, Shenyang, Department of Pharmaceutical Analysis, School of Pharmacy, Shenyang Pharmaceutical University, Shenyang

Graphical Abstract:



Read Full-Text article