Gas Chromatographic Method for Estimation of Organic Volatile Impurities in Some Ayurvedic Preparation

Abstract

Impurities in pharmaceuticals are undesired chemicals that are remaining with the active pharmaceutical ingredients (APIs) or developed during formulation, or upon aging of both API and formulated APIs to medicine. The presence of these undesired chemicals even in small amount may influence the efficacy and safety of the pharmaceutical products. The control of pharmaceutical impurity is a critical issue. Residual solvents in pharmaceuticals (commonly know as organic volatile impurities or OVIs) are organic volatile chemicals that are either used or produced during the manufacturing of active pharmaceutical ingredients, excipients and drug products and may be hazardous to human health. Residual solvents have no therapeutic benefits but may be hazardous to human health and to the environment, they are either not present in the products or are present only below acceptable levels. However, their acceptances limit and classification vary among the three major pharmacopoeias, USP, PhEur and JP. In the development and manufacture of chemical and pharmaceuticals, analytical chemistry plays a vital role in the quality control of the intermediate and final products. 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.