Abstract

DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF 2- CHLOROMETHYL-1H BENZIMIDAZOLE IMPURITY IN AZILSARTAN MEDOXOMIL BULK AND FORMULATION

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

Abstract

The process related impurity of Azilsartan Medoxomil i.e: 2- Chloromethyl-1 H benzimidazole was synthesized, characterized and quantified in bulk and formulation. The synthesis of intermediate was carried out by benzimidazole synthesis process using Ophenylenediamine, chloroaceticacid, in presence of 5N HCl. The percentage yield was found to be 85%. Recrystallization and purification of impurity was done. The preliminary evaluation was done on laboratory scale via melting point, elemental analysis and TLC. The melting point of impurity was found to be 153-1550C. The TLC of impurity was carried by using Chloroform: Methanol (9:1) and the R f was found to be 0.68. The process impurity was synthesized, purified and characterized by IR, 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 2-Chloromethyl-1HBenzimidazole impurity was quantified from Azilsartan medoxomil bulk and its marketed tablet formulation.

Keywords: Validation, Azilsartan Medoxomil, Impurity.