Related Substances of Ezetimibe and Simvastatin in Combined Dosage Form

What is it about?

Identification and quantification of impurities in drug compounds is a crucial task in pharmaceutical process development for quality and safety. Related components are the impurities in pharmaceuticals which are unwanted chemicals that remain with the active pharmaceutical ingredients (APIs), or develop during stability testing, or develop during formulation or upon aging of both API and formulated APIs in medicines. The presence of these unwanted chemicals even in small amounts may influence the efficacy and safety of the pharmaceutical products. Various analytical methodologies were employed for the determination of related components in pharmaceuticals. There is a great need for development of new analytical methods for quality evaluation of new emerging drugs. The research work presents chromatographic separation of drugs and impurities in the combined dosage form. This is significant because it is very challenging task to separate impurities and degradation products of two different drugs in combined dosage forms. The paper should be of interest to readers in the areas of separation science in Chromatography.

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Why is it important?

As per survey, about 20% people in world are suffering from hypercholesterolemia. Combined therapy of Ezetimibe with a Simvastatin provides an incremental reduction in LDL cholesterol levels. Also co-administration of Ezetimibe with Simvastatin could significantly reduce the risk of coronary heart disease events in patients with hypercholesterolemia. As we talk about the physical properties of these drugs, Ezetimibe is more polar molecule than Simvastatin. Degradation impurities of Simvastatin are polar in nature as it contains carboxylic acid group. It is a very challenging work to separate of Simvastatin impurities from Ezetimibe and Ezetimibe impurities in a single method. We have developed a rugged and robust method in which we can easily quantify impurities of Simvastatin and Ezetimibe simultaneously. As in this method we have used simple solvents which are easily available and separation was achieved by C18 column which is also easily available. Mobile phase contains high amount of solvent, which will lengthen the column life and run time of this method is very short. So by considering all this parameters, we can say that this research work is novel and also we can apply this method in QC for routine analysis related substances of Ezetimibe and Simvastatin.

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