Document Type : Original Article
Authors
1
Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Assiut University, Egypt
2
Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Sphinx University, New Assiut 10, Egypt
Abstract
Near-infrared (NIR) spectroscopy has long been used for quantitative and qualitative analysis. It offers the advantages of being rapid and non-destructive technique. Pharmaceutical analysis is always concerned with active pharmaceutical ingredients (APIs), while no focus is done on the analysis of excipients used in pharmaceutical dosage forms. In this study, the NIR spectra of most commonly used excipients are presented, the interpretation of such spectra can be used as a reference in counterfeit tracing during pharmaceutical analysis. In this article, twenty two excepients are studied which fall into seven classes: disaccharides [β-lactose anhydrous, α-lactose monohydrate and sucrose], polysaccharides [corn starch, wheat starch, sodium starch glycolate, maltodextrin, croscarmellose sodium, microcrystalline cellulose, hydroxypropyl cellulose and hypromellose (hydroxypropylmethyl cellulose)], a fatty acid and its salt [stearic acid and magnesium stearate], a carboxylic acid salt [potassium sorbate] inorganic compounds [calcium carbonate, dibasic calcium phosphate, silicon dioxide and talc], an anionic surfactant [sodium lauryl sulphate (sodium dodecyl sulphate)] and unclassified compounds [calcium ascorbate, candelilla wax and polyvinylpyrrolidone]. Counterfeit tracing was applied for samples representing each class of excipients by examination of their NIR spectra followed by comparison with the related spectra of the standards
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