Abstract

DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF 1H, 1’- H-2, 2’-BIBENZIMIDAZOLE IMPURITY IN TELMISARTAN BULK AND FORMULATION

Poonam P. Patil*, Dr. Veena S. Kasture and Dr. K. Vanitha Prakash

Abstract

process related impurity of Telmisartan i.e: 1H, 1’-H-2,2’- Bibenzimidazole was synthesized, characterized and quantified in bulk and formulation. The synthesis of intermediate was carried out by using O-phenylenediamine, oxalic acid. The percentage yield was found to be 78 %. Purification of impurity was done by rescrystallization. The preliminary evaluation was done on laboratory scale via melting point, elemental analysis and TLC. The melting point of impurity was found to be 310-315 0 C. The TLC of impurity was carried by using Chloroform: Methanol: Ethyl Acetate (3:2:1) mobile phase and the R f was found to be 0.65.The process impurity was synthesized, purified, and characterized by IR, 1H-NMR and UV method was developed for quantification of synthesized impurity. The method was validated as per ICH Q2B guidelines. The UV method was found to be linear, precise, accurate, robust and rugged. Finally 1H, 1’- H-2,2’-Bibenzimidazole impurity was quantified from Telmisartan bulk and its marketed tablet formulation.

Keywords: Validation, Telmisartan, Impurity, 1H, 1’-H-2,2’-Bibenzimidazole.