Quetiapine Used for Chronic and severe Mental Disorder
Quetiapine is a neuroleptic drug categories to the class of dibenzothiazepines. It is used as a hemifumarate salt. Quetiapine is an opponent of a broad range of neurotransmitter receptors. It is an uncharacteristic antipsychotic drug used to handling of schizophrenia and other psychotic syndromes (1ñ3). One of the most vital challenges of current life sciences research is the comprehensive and perfect analysis of various forms of the trouble. Therefore, it is very important to grow highly specialized analytical tools allowing a simple, fast and accurate determination of scums in water, soil or in active pharmaceutical ingredients (API).
An API should be categorized by properties which assurance its safety and efficacy. The pharmaceutical industry, as the main manufacturer of API, is liable for their quality. There are three conditions of the quality valuation of an API: product uniqueness, assay criterion and cleanliness criterion referring to impurities. Impurity is measured as any by-product occurring in the active material, which desires to be controlled, even if it is entirely neutral or its pharmacological properties are healthier than that of the API’s.
According to another meaning, it is any component of the new API which is not a chemical entity defined as an API. There are diverse sources and types of impurities which can occur in an API. Pharmaceutical impurities contain of process-related impurities and dilapidation products both to be measured as API constituents. Many potential impurities come from the developing process of API and contain of starting materials, intermediates, reagents, solvents, catalystand by-products.
These possible impurities should be considered in order to determine the mechanisms of controlling the engineering process of API with the aim of, on one hand, removing them, and on the other, including them in the specification for routine resistor at accepted levels. Early understanding of the environment and mechanism of impurity creation enables to incorporate a control strategy into the engineering process. It is also vital to study impurities in starting materials used in the API amalgamation.
There are only very few reports on this source of impurities in APIs, however, the risk of impurity of API in this way is very high. Impurity control in drug products is the main goal of drug growth. Stringent global regulatory requirements regarding impurities have been deliberated for several years and outlined in the international conference on harmonization (ICH) guidelines Q3A(R), Q3B(R) and Q3C.
All these features and requirements indicate a new trend of learning an impurity profile rather than a purity profile. The classification of the impurity profile of the new drug products was reported by ICH as ìdescription of recognized and unknown impurities existing in the new DSI. It is the common name of investigative activities with the goal of detecting, identifying or explicating the structure and quantitative determination of organic and inanimate impurities as well as remaining solvents in APIs.
Of the three groups of scums mentioned above the estimation of the profile of organic impurities is the most challenging and interesting task. A variety of techniques are available for monitoring impurities. These can include spectroscopic and separation methods or a combination of both. The ideal method should be specific, selective, precise, correct and extremely sensitive.
Nowadays, it is becoming conceivable, due to the use of technologies coupled with mass spectrometry, which allow to determine the identity, purity and assay of studied substances simultaneously. Impurity monitoring in APIs is often limited to the analysis of the known compounds, whereas the unknown compound analysis, as more complicated one, requires instrumental methods to obtain structural information. Liquid chromatography-mass spectrometry (LC-MS) has become the primary approach for the identification of low-level impurities in samples ensuing from synthesis or from dilapidation of APIs. Full scan and product ion examination analysis, providing molecular weight information and fragmentation data, respectively, offer rich structural information on candidate structures. There are many strategies to identify impurities.
The one described in this article involves the use of the parent drug itself as a template for the interpretation of the unknown structures. First, the parent drug is analyzed with LC-MS. The retention time and molecular weight information are obtained. Using LCMS/MS, the production examination of the parental drug is obtained, and precise product ions and unbiased losses are assigned to the substructures of the molecule. The MS/MS identification strategy is based on the assumption that much of the parent drug structure will be retained in the impurities or decomposition products.
The production mass spectrum of the parent drug and disintegration pattern of the parent drug are used as the patterns for the identification of the unknown construction. In this paper the typical experimental setup is described that is used routinely for LC-MS/MS tests. Representative applications of the approach are also given in operational elucidation of impurities in APIs. The multidimensional evaluation of impurity profiles by LC-MS/MS coupling is illustrated on quetiapine as an API.