An innovative method, interference subtraction, for determination of drugs in syrups in presence of potential interfering excipients

Research Abstract

Pharmaceutical dosage forms contain both active ingredients and inactive materials called exipients, most of which cause high interference specially in direct UV-spectrophotometry. This problem is highly obvious in syrups which may contain preservatives, coloring agents, thickening agents and sweetening agents. Thus, there is an urgent need to develop and validate a simple, accurate and selective method named interference subtraction method for determination of drugs in syrups in presence of these excipients without pre-separation by solving this interference. This newly designed method was successfully applied to; Oxybutynin hydrochloride in Detronin® syrup, Ambroxol hydrochloride in Muco® syrup and Ibuprofen in both Brufen® syrup and Megafen N® oral suspension. These chosen syrups contain different excipients causing different types of interference. This innovative method was validated according to ICH guidelines. The results obtained by interference subtraction method were statistically compared with those obtained by the official and /or reported methods of the proposed drugs.

Research Keywords

Interference, subtraction , oxybutynin, ambroxol, ibuprofen.