IOSR Journal of Applied Chemistry (IOSR-JAC) e-ISSN: 2278-5736.Volume 10, Issue 7 Ver. I (July. 2017), PP 27-34 www.iosrjournals.org DOI: 10.9790/5736-1007012734 www.iosrjournals.org 27 |Page Impurity Profiling of Pharmaceutical Drugs By Various Methods Shwetali K. Churi 1 , 2 Manohar V. Lokhande 3* 1 Research Scholar, Shri Jagdishprasad Jhabarmal Tibrewala University , Jhunjhunu-333001, Rajasthan , India. 2 Department Of Chemistry, Viva Institute Of Technology, Shirgaon, Virar(East),Vasai, Dist-Palghar-401305, Maharashtra, India. 3* Department Of Chemistry, Sathaye College, Vile Parle (E), Mumbai-400057, Maharashtra, India Abstract: Analysis is the basic in every product or service and is very essential in drugs as it deals with life. Analytical chemistry is the study of material with respect to its qualitative and quantitative composition. In order to ensure the safety and efficacy of all drugs throughout all phases of its life shelf, considering its storage, distribution and use, every pharmaceutical product should be analytically monitored to find the impurity level in any pharmaceutical drug with the help of new techniques and methodologies like UV Spectroscopy, IR Spectroscopy, Mass Spectrometry, NMR spectroscopy and HPLC Methods. Keywords: Validation of Drug, HR/AM/MS , LOD, LOQ,LC-MS and HPLC I. Introduction Impurity profiling or Characterization refers to the broad and general process to refer any materials analysis process including macroscopic techniques such as mechanical testing, thermal analysis and density calculation which ranges from angstroms to centimeters, such as in the imaging of coarse grain structures in metals and finding the impurity level in any pharmaceutical drug with the help of new techniques and methodologies. a) Ultraviolet (UV)Spectroscopy, b) Infrared (IR)Spectroscopy, c) Mass Spectrometry (MS), d) Nuclear Magnetic Resonance (NMR), e) HPLC Methods[1-2]. Various regulatory authorities like United States Food Corporation and Drug Authority (USFDA), European Directorate of Quality Medicine (EDQM), Therapeutic Goods administration , World Health Organization (WHO) and other health agencies are emphasizing on the purity requirements. A key component of the overall quality of a pharmaceutical is control of impurities, as their presence, even in small amounts, might also affect safety and efficacy of drug. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines are developed [3] with the joint efforts of regulators and industrial representatives from the European Union, Japan and the United States. The guidelines helped to ensure that, the unlike regions have consistent necessities for the record that should be submitted to the various regulatory agencies. As per ICH Q3A(R) and ICH Q3B(R) guidelines, unknown impurities related to bulk drug and dosage form, more than the identification threshold must be identified[4].Sources of Impurities: The different sources of impurities are given below: Crystallization-related impurities: Residual solvents or organic volatile chemicals occur during crystallization of the bulk drug substance. Impurities originating from synthetic processes of the drug substance: Starting materials and intermediates are the chemical constructing blocks used to construct the final form of a drug substance molecule. Un-reacted starting materials and intermediates can potentially survive the purification process and appear in the final product as impurities, by-products formed from the side-reactions in drug synthesis accounts the common impurities in drugs. Chemically active reagents, metallic ligands, and various catalysts used in the synthesis of a drug substance can be carried over to the final products as trace level impurities. Impurities arising during storage: Degradation of the drug substance is one of the main sources of impurities caused by chemical instability of the drug substance under the conditions (e.g., heat, moisture, solvent use, pH, light, etc.) of manufacturing, isolation, purification, drying, storage, transportation, and interactions with other chemical entities in the formulation. Identification and Characterization of Impurities: Initial step is to identify the impurities by different methods like reference standard method, separation methods and isolation method, further the characterization of impurities can be carried out using spectroscopic, spectrometric and hyphenated techniques. Reference standard method: If the initial analysis shows that the observed impurity falls into the standard impurity category, the impurity identification turns into practice which can be achieved by three experiments analysis of sample, followed by analysis of standard and lastly mixture of sample with standard by applying any of chromatographic or spectroscopic techniques. Separation methods: The methods used for the separation of impurities and degradation products are generally as follows high performance liquid chromatography (HPLC), gas chromatography (GC) etc.