Assay validation for an active ingredient in a pharmaceutical formulation: practical approach using ultraviolet spectrophotometry

Abstract

The determination of diclofenac sodium in tablets is presented as an example of an assay validation using spectrophotometry. The experimental design and different statistical approaches are given.

Simultaneous determination of diclofenac and its common counter‐ions in less than 1 minute using capillary electrophoresis with contactless conductivity detection

“…Several methods have been proposed for the determination of DCF in pharmaceutical samples, which are based on spectrophotometry , LC , CE , electrochemistry , Raman spectroscopy , fluorimetry , and gravimetry . However, all these methods allow only the determination of DCF without obtaining information about its respective counter‐ion.…”

Potentiometric behaviour of ion selective electrodes based on iron porphyrins: The influence of porphyrin substituents on the response properties and analytical determination of diclofenac in pharmaceutical formulations

“…As a result, this non-steroidal drug presents anti-inflammatory, analgesic and antipyretic properties [13] being often used as an adjuvant on the treatment of chronic diseases like arthritis and glaucoma. Regarding its therapeutic relevance different methodologies have been proposed for the determination of sodium diclofenac in pharmaceutical formulations, namely spectrophotometry [14][15][16][17][18][19][20][21][22][23], fluorimetry [24][25][26][27], potentiometry [28][29][30], chromatography [31][32][33], and nuclear magnetic resonance spectroscopy [34]. From all those techniques, potentiometric methods, resorting to ion selective electrodes (ISEs) are considered an advantageous analytical tool, especially for the analysis of complex matrices such as pharmaceutical preparations [35], mainly considering its selectivity, price and analytical range.…”

Sensitive and Simple Determination of Diclofenac Sodium by Use of a Continuous Flow-Injection Procedure with Solid-Phase Spectroscopic Detection

“…9,21 It should be emphasized that there is a high tolerance level of the method to the presence of paracetamol: the same FIA UV spectrophotometric procedure in a homogeneous solution tolerates only a 0.67 (w/w) ratio paracetamol/DS against a 25 (w/w) ratio in the proposed method, that is, about 40-times higher. This fact allows the determination of DS in pharmaceuticals also containing paracetamol.…”

“…It has been determined by a variety of analytical techniques, such as colorimetry 6,7 , ultraviolet [8][9][10][11] and visible [12][13][14][15][16][17][18] spectrophotometry, fluorometry 19 , gas [20][21][22] and liquid [23][24][25] chromatography, and flow injection analysis with spectrophotometric detection. 26 Spectrophotometric methods provide practical and economical advantages over other ones.…”