Forced Degradation and Stability Indicating Studies for Clomifene Citrate Tablet
Zarwali Khan
Department of Chemistry, Faculty of Science, Agriculture University Faisalabad, Pakistan.
Maria Yaseen
M.C.P.S Peads Resident (CMH Multan), Pakistan.
Ihsan Ali *
Higher Education Department (HED), Govt. of Punjab, Lahore 54000, Pakistan.
Ammara Yaseen
Institute of Chemical Sciences Bahauddin Zikriya University, Multan, Pakistan.
Bakar Bin Khatad Abbasi
Department of Chemistry and Chemical Biology, Northeastern University, Boston, MA 02115, USA.
Arslan Ali
Department of Chemistry, Faculty of Science, Agriculture University Faisalabad, Pakistan.
Khalid Mehmood
Institute of Chemical Sciences Bahauddin Zikriya University, Multan, Pakistan.
Muhammad Ibrahim
Department of Mathematics, National Textile University, Faisalabad, Pakistan.
Tayyaba Shabir
Department of Chemistry, Ghazi University, Dera Ghazi Khan, Pakistan.
Fakiha Nazakat
Department of Chemistry, Govt Graduate College Toba Tek Singh 36050, Pakistan.
Zobia Yaseen
Department of Chemistry, Faculty of Science, Agriculture University Faisalabad, Pakistan.
Nasir Abbas
Department of Chemistry, Quaid-e-Azam University, Islamabad 45320, Pakistan.
*Author to whom correspondence should be addressed.
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.
Keywords: Pharmaceutical medications, clomifene citrate tablets, drug substance, degradation