Journal of Engineering, Computers & Applied Sciences (JEC&AS) ISSN No: 2319-5606 Volume 2, No.10, October 2013 www.borjournals.com Blue Ocean Research Journals 1 HPLC: An Analytical Technique for Pharmaceutical Validation of Omeprazole V.Malik, Department of Pharmaceutical Sciences, Hindu College of Pharmacy, Sonepat, (HR) India S. Jain, Department of Pharmaceutical Sciences, Hindu College of Pharmacy, Sonepat, (HR) India P.Malik, Department of Biotechnology, Maharishi Markandeshwar University, Mullana (Ambala), (HR) India Abstract Healthcare advances have been receiving increasing attention since the last few decades. Several fatal and clinically tough physiological complications such as cancer, diabetes, cardiovascular complications, malformations or improper coordination of brain with rest of the body, have been the major thrust areas that have kept the molecular biologists at bay and forced them to continuously ponder over the drug synthesis strategic mechanisms. In this context, omeprazole is the drug frequently used to treat the excess acidity of gastrointestinal region of living organisms. The commercial synthesis of this and related generic drugs has been a topic of concern because this involves multiple steps and a throughput screening of the synthesized intermediates before the final drug extraction actually takes place. This review article highlights the purification, characterization and validation strategies of drug omeprazole and its associated intermediates, which have a very sharp influence on the nature of drug synthesized. The characterization and testing techniques such as those of High Pressure liquid Chromatography (HPLC), spectroscopic analysis have also been discussed. Keywords: Healthcare, Physiological, Cardiovascular, Gastrointestinal, Intermediates, Omeprazole, Chromatography, Spectroscopic. 1. Introduction A drug is a biochemical formulation other than food which when put into human body produces medical, intoxicating, remedial or performance enhancing effects. The most popular motive driving the synthesis of drugs has been their use in the treatment, cure and prevention of diseases or to enhance the state of physical or mental well-being. Along with drugs, there are a number of additional substances associated known as impurities which affect the purity of material of interest, which is the active intact drug formulation. The surprising fact of these impurities is that these are not always quality wise deteriorating in nature. Pharmacologically, a drug gets negatively influenced from the point of view of its functional performance even if the impurity associated with it is not chemically deteriorating in nature. This is so as this association has a mark on the intended function of the drug to be synthesized. Talking about the nature of impurities generally associated with a drug, the terminology has been extremely wayward to address these. Quite often these impurities are known by the names as variable as intermediates, transformation products, degradation products, penultimate intermediates, by-products or sometimes even chemically dissimilar isomer [1]. Otherwise purity or nativeness of functional performance is a very complex issue influenced by a number of other factors. This is so because most of the drug formulations are organic and chiral in nature. A number of outside materials are of such nature that these alter with organic characteristics of drug formulation, the individual contributions and relative compositions of each of ingredients and a whole lot of other factors exist which affect the desired chemical activity of a drug formulation. This is because the composition of each of the components is fixed and the chemical basis on which a particular drug has been synthesized is the law of fixed proportions, which says that a chemical compound is formed by the combination of a fixed composition of each of its ingredients, irrespective of its source or place of availability. Similarly, if we mix the ingredients in a definite ratio only then we can achieve the specific function for which the drug has been manufactured. All other combinations of ingredients would result in some other effect that can be weaker or even sometimes aggravating in nature. Further, the viable storage of a drug also shapes up its relative feasibility to last for a definite time limit. This is why the drugs which are to be administered intravenously or intradermally are stored manufactured as well as stored in contrastingly different manners. These kinds of influences are highly variable in nature and consequently their effects are equally wayward. An important factor affecting the desired quality drug synthesis is the chemical nature and physical state of impurity concerned. It is therefore highly urgent that specific and additional precautions should be of paramount measures in order to ensure a proper drug synthesis. Several