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Abstract
In formulations or medicinal preparation the Active Pharmaceutical Ingredient are the substances, which are responsible for therapeutic activity. The quality of a medicinal preparation is related to all the factors, which contribute directly or indirectly to the safety, stability effectiveness & acceptability of the products. These molecules are obtained from various sources like naturally occurring substances, semi synthetic and synthetic routes. Therefore the quality must be built in the products during the research and development stage of the product itself. A large number of appropriate reagents solvents and synthetic routes are used to bring about the reaction of a pharmaceutically active molecule. As a result during the preparation of the molecule many unwanted but related compounds and byproducts may form along with the required molecule. Appropriate methods are developed to purify the reaction product to obtain the Active Pharmaceutical Ingredient to maximum purity. These impurities are also termed as related substance in the Pharmacopoeia or official texts. These impurities when they are present within the limits prescribed in the pharmacopoeia are harmless. Thus it is necessary to have these impurities in a pure form, so that we can compare the purity of the drug. In the present study related substance of cephalexin an antibiotic drug were synthesized, and the impurities are then compared identified and quantified using analytical methods such as HPLC.
Key Words
Cephalexin, HPLC, active pharmaceutical ingredient, therapeutic activity.
Introduction
Impurity is defined as any substance coexisting with the original drug, such as starting material or intermediates or that is formed, due to any side reactions. Impurity can be of three types: Impurities closely related to the product and coming from the chemical or from the biosynthetic route itself, Impurities formed due to spontaneous decomposition of the drug during the storage or on exposure to extreme conditions, or the precursors which may be present in the final product as impurities. Impurities present in excess of 0.1% should be identified and quantified by selective methods. The suggested structures of the impurities can be synthesized and will provide the final evidence for their structures, previously determined by spectroscopic methods. Therefore it is essential to know the structure of these impurities in the bulk drug in order to alter the reaction condition and to...