Abstract
Background: Attenuated total reflection-Fourier transform infrared (ATR-FTIR) spectroscopy is a rapid quantitative method which has been applied for pharmaceutical analysis. This work describes the utility of first derivative ATR-FTIR spectroscopy in the quantitative determination of diclofenac sodium tablets. Methods: This analytical quantitative technique depends on a first derivative measurement of the area of infrared bands corresponding to the CO stretching range of 1550-1605 cm -1. The specificity, linearity, detection limits, precision and accuracy of the calibration curve, the infrared analysis and data manipulation were determined in order to validate the method. The statistical results were compared with other methods for the quantification of diclofenac sodium. Results: The excipients in the commercial tablet preparation did not interfere with the assay. Excellent linearity was found for the drug concentrations in the range 0.2 - 1.5 w/w %. (r 2= 0.9994). Precision of the method was assessed by the repeated analysis of diclofenac sodium tablets; the results obtained showed small standard deviation and relative standard deviation values, which indicates that the method is quite precise. The high percentage of recovery of diclofenac sodium tablets (99.81, 101.54 and 99.41%) demonstrate the compliance of the obtained recoveries with the pharmacopeial percent recovery. The small limit of detection and limit of quantification values (0.0528 and 0.1599 w/w %, respectively) obtained by this method indicate the high sensitivity of the method. Conclusions: First derivative ATR-FTIR spectroscopy showed high accuracy and precision, is considered as nondestructive, green, low cost and rapid, and can be applied easily for the pharmaceutical quantitative determination of diclofenac sodium tablet formulations.
Highlights
Diclofenac sodium (DS) is a nonsteroidal anti-inflammatory drug (NSAID) that is known for its potent pharmacologic activity
This work aims to expand on previous reports exploring quantitative Fourier transform infrared (FTIR) approaches to quantitatively determine the active pharmaceutical ingredient (API) in a number of DS tablet dosage forms
Linearity The proportional relationship between the area under the curve (AUC) and concentration was evaluated by constructing a linear regression of five concentrations (0.2, 0.4, 0.6, 0.8, 1%)
Summary
Diclofenac sodium (DS) is a nonsteroidal anti-inflammatory drug (NSAID) that is known for its potent pharmacologic activity. Several quantitative analytical methods have been implemented to test the active pharmaceutical ingredient (API) of DS in its various marketed dosage forms. These quantitative approaches include high performance liquid chromatography (HPLC)[2,3,4], gas chromatography[5], UV–visible spectrophotometry[6], spectrofluorometry[7], densitometry[8], potentiometry[8,9], and Raman spectroscopy[10,11]. Conclusions: First derivative ATR-FTIR spectroscopy showed high accuracy and precision, is considered as nondestructive, green, low cost and rapid, and can be applied for the pharmaceutical quantitative determination of diclofenac sodium tablet formulations
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