Spectrophotometric strategies for the analysis of binary combinations with minor component based on isoabsorptive point's leveling effect: An application on ciprofloxacin and fluocinolone acetonide in their recently delivered co-formulation.

Comparative study of the spectrophotometric strategies utilizing the isoabsorptive point present in overlapped absorption spectra of ciprofloxacin and fluocinolone acetonide in their recently delivered co-formulation, was presented. Four spectrophotometric approaches were developed, dependent on the determination of the leveling effect of isoabsorptive point in their zero order absorption spectra or its manipulated form ratio spectra as it retains an isosbestic point. The proposed strategy was based on determination of the total concentrations of the proposed drugs at iso-point, either via zero order or ratio spectra, while one of the recommended methods determined the concentration of the major component, so the concentration of the minor component was obtained by differentiation. The first, second and third methods are utilizing isoabsorptive point at zero order absorption spectrum to quantify total concentration of the cited component, while the major component could be selectively determined using either absorbance at its maxima (IsoPD0-D0max), or area under the peak method (IsoPD0-AUC), or first derivative technique (IsoPD0-D1). The fourth method is ratio manipulated isoabsorptive point in ratio spectrum, namely the amplitude modulation method (AM), using an unified regression equation for the total and major component concentrations, separately. The four methods were applied practically for the analysis of the binary mixtures of ciprofloxacin hydrochloride (CIP) and fluocinolone acetonide (FLU) in a recently otic solution form in challengeable ratio12:1respectively, without the need of any previous stages such as separation, dilution or standard addition. The methods were successfully validated as per ICH guidelines. The outcomes data gained from those submitted techniques were statistically assimilated with official ones. However, no radical differences were noticed.

Combined use of algorithms for peak picking, peak tracking and retention modelling to optimize the chromatographic conditions for liquid chromatography-mass spectrometry analysis of fluocinolone acetonide and its degradation products.

A strategy for rapid optimization of liquid chromatography column temperature and gradient shape is presented. The optimization as such is based on the well established retention and peak width models implemented in software like e.g. DryLab and LC simulator. The novel part of the strategy is a highly automated processing algorithm for detection and tracking of chromatographic peaks in noisy liquid chromatography-mass spectrometry (LC-MS) data. The strategy is presented and visualized by the optimization of the separation of two degradants present in ultraviolet (UV) exposed fluocinolone acetonide. It should be stressed, however, that it can be utilized for LC-MS analysis of any sample and application where several runs are conducted on the same sample. In the application presented, 30 components that were difficult or impossible to detect in the UV data could be automatically detected and tracked in the MS data by using the proposed strategy. The number of correctly tracked components was above 95%. Using the parameters from the reconstructed data sets to the model gave good agreement between predicted and observed retention times at optimal conditions. The area of the smallest tracked component was estimated to 0.08% compared to the main component, a level relevant for the characterization of impurities in the pharmaceutical industry.

Are generic formulations equivalent to trade name topical glucocorticoids?

Trade name glucocorticoid formulations triamcinolone acetonide, fluocinolone acetonide, and betamethasone valerate were compared with their generic equivalents because of increasing substitution of generic formulations for trade name formulations. The vasoconstrictor assay was the method used for these comparisons. Large differences were found between generic and trade name formulations containing the same steroid in the same concentration in both cream and ointment vehicles. If generic substitutions are to be used for trade name formulations, the physician must be aware that significant differences in therapeutic effectiveness may be expected.