Abstract

Validation of Gas Chromatographic System for Estimation of Organic Volatile Impurities in Hydro-Alcoholic Formulation

Author(s): R. A. Hajare, R. M. Gaurkhede, P. P. Chinchole, S. V. Deshmane, A. V. Chandewar and S. S. Karki

Separation methods occupy an important place in the array of available analytical techniques, depending on the nature of the compounds. Gas chromatography methods continue to be used to a large extent, especially in automated routine controls. The use of specialized injection and detection methods has further increased its field of applications. The synthesis of an active pharmaceutical ingredient (API) normally consists of several synthetic steps. Process-related impurities can be formed at any step and could ultimately appear in the final drug substance, particularly in the scale-up drug candidates. Impurities must be controlled because of their potential toxicity. Impurity control is a continuing concern of regulatory agencies and the pharmaceutical industry. The International Conference on Harmonization (ICH) was formed in the 1990s to coordinate the technical requirement for the registration of pharmaceuticals in the European Union, Japan and the United States. ICH has issued the guideline “Impurities in New Drug Substances, ” recommending that, for a maximum daily dose of less than or equal to 2 g per day, any impurity at the 0.10% level (or 1 mg per day intake, whichever is lower) must be identified. The Food and Drug Administration (FDA) has adopted the ICH guidelines and has published the guidelines in the Federal Register.