A Review On Techniques For Estimation Of Nitrosamine Impurities In Antidiabetic Drugs Pioglitazones And Glifizones, Metformin

Abstract

Nitrosamine is family of carcinogenic impurities. Which are formed by reactions of secondary amide carbamates, amines, derivatives of urea with nitrite and other Nitrogenous agent. The contaminated starting or law materials supplies by vendor may be introduced Nitrosamine impurities in drug product. The methods of nitrosamine testing in sartan include the use of chromatographic techniques (reversed phase liquid chromatography combined with mass spectrometry (MS) etc. Impurities are undesirable chemicals present in the pharmaceuticals arising from normal manufacture. They are not chemicals accidentally or maliciously introduced. Impurities have no therapeutic value and are potentially harmful. Impurities are generally assumed to be inferior to API because they might not have the same level of pharmacological activity. Presence of impurity in the drug substance compromises the purity of the drug contains superior pharmacological or toxicological properties. Impurities in drug substance can emerge from various sources and phases of the synthetic process. During synthesis, intermediates and by-products may be carried into the drug substance as impurities or become a source of other impurities resulting from them. Impurities present in starting material may be carried into drug substance. Diabetes mellitus is a syndrome of chronically elevated glucose level in the blood either due to insulin resistance, insulin deficiency or both. The different analytical methods available for the estimation of the drugs which will provide the knowledge of the analysis and it can be utilized for the determination of targeted drugs (anti diabetic drugs) to enhance the therapeutic benefits of anti diabetic drugs.