Development of a Novel Method for the Analysis of the Drug in Low Concentration Using an Antidiabetic Drug ‘Voglibose’ for the Study

摘要

Aim: To develop a novel method for the analysis of the drug in low concentration using an anti diabetic drug ‘voglibose’ for the study. Study Design: Analysis of the drug plays an important role in its development. Assay and content uniformity are the two tests required for establishing quality of a pharmaceutical product. Drug dissolution testing is routinely used to provide critical in vitro drug release profiles. Normally, all these tests are done using HPLC to obtain and analyze the chromatograms but, this procedure becomes challenging as the concentration of the drug reduces. In such conditions, alternative methods have to be established or different instruments have to be used. Voglibose is one such antidiabetic drug which is used in very low concentrations (0.2 mg to 0.3 mg per tablet) in pharmaceutical industries for the treatment of postprandial hyperglycemia. The existing methods of analysis for assay and content uniformity have a number of challenges. In dissolution studies the drug gets diluted to further lower levels and hence the conventional methods do not produce any results. Currently no method is available for dissolution studies for this drug. Thus the paper aims at establishing a suitable method for the analysis of the drug. Methodology: The main aim of this work is to develop a common method suitable for the analysis of the drug. The paper mentions of applying the concepts of drug enzyme interaction as a method of transduction for the analysis of the drug. Silicon wafer surfaces were used as a sensor surface to study the drug- enzyme interactions which caused fluorescence and florescent images were obtained by the fluorescent microscope and further processed using image processing techniques to quantify the concentration of the drug. Results: It was observed that fluorescence was obtained only due to drug enzyme interaction. The corresponding fluorescent images were captured and their intensity values were analyzed using image processing techniques and the concentrations of different samples were quantified. The method is also used to quantify the concentrations as used in dissolution method. There were other two samples prepared which mentions that fluorescence is not observed by single coating either alpha amylase or voglibose on the silicon surfaces. Conclusion: This work was successfully carried out towards developing a common method suitable for the analysis of the drug-“Voglibose” used in low concentration; for all the parameters including assay, content uniformity and dissolution. This work also contributes for dissolution studies for the drug which had no methods available till date for quantifying the concentration of the drug corresponding to 0.3mg in 900ml of buffer. Thus the work establishes a novel method that can be used by the pharmaceutical industry for the analysis of drug in low concentrations.