No abstract

Impurities can be closely related to the product that is formed during the synthesis of a bulk drug or it can be decomposition product formed during the storage of the drug. The International Conference on Harmonization (ICH) has published guidelines on impurities in new drug substances, products and residual solvents. According to ICH guidelines, an impurity should not exceed 0.1 % and total impurity should not exceed 1.0 % in manufacturing each batch of the drug (1, 2). Impurities present in excess of 0.1 % During the manufacture of bulk drug midazolam various impurities arised that can be the related products or degradation products. Structures of eight impurities that can arise during the manufacture of bulk drug midazolam were proposed. In the present work, synthesis of these impurities and their characterization by different spectroscopic techniques have been done. HPLC method was developed for the separation of impurities from the bulk drug. The developed method separates midazolam from its eight impurities/degradation products within a run time of 45 min.