Forced Degradation and Stability Indicating Studies for Clomifene Citrate Tablet

Abstract

Pharmaceutical medications must be stable to preserve their efficacy and safety over the period of their shelf lives. Studies on force degradation are crucial for identifying probable degradation pathways and identifying extreme stresses that may lead to the breakdown of the pharmaceutical product. This report offers a thorough analysis of the force degradation tests performed on Clomifene citrate tablets. Evaluation of the effects of several stress factors, including temperature, humidity, light, and mechanical forces, on the stability of clomifene citrate is the main goal. To replicate actual storage and handling situations, the study used stress testing criteria specified by the International Conference on Harmonization (ICH). According to the study, temperature and humidity have the biggest roles in the degradation of Clomifene citrate tablets. In this article the FDS was performed by using a stainless-steel column (250 mm x 4.6 mm) packed with Butylsilane C4 (5µm) L26, detector 233nm, mobile phase; mobile Phase was prepared by mixing 550 volumes of methanol, 450 volumes of water and 3 volumes of triethylamine. Then adjust the pH to 2.5 with phosphoric acid. Flow rate; 1 mL/mint. The quantification and hyphenation of the instrumental analysis were successfully accomplished using the developed method.