Abstract
Objective: To develop and validate simple, rapid and sensitive spectrophotometric method for the assay of four antimuscarinic antagonists, namely oxybutynin (OXB), solifenacin (SOL), tolterodine (TOL) and fesoterodine (FES) in bulk and pharmaceutical formulations.Methods: The proposed method is based on the reaction of the selected drugs with eriochrome cyanine R (ECR) in buffered aqueous solution at pH 1.0. The formed ion-pair complexes were extracted with dichloromethane and measured quantitatively with maximum absorption at 464 nm. All variables that affect on color intensity such as pH, buffer volume and concentration of ECR and extractive solvents were studied and optimized.Results: The calibration graphs were linear over the concentration range of 4–24, 4–32, 4–32 and 2–22 mg/ml for OXB, SOL, TOL and FES, respectively. The stoichiometry of the reaction was found to be 1:1 in all cases. Molar absorptivity values were found to be 2.043×104, 1.856×104, 1.798×104 and 2.856×104 l/mol/cm for OXB, SOL, TOL and FES, respectively. Excipients which used as an additive in commercial formulations did not interfere in the analysis.Conclusion: The developed method was successfully applied to determine OXB, SOL, TOL and FES in pharmaceutical preparations. The developed method can be used for quality control and routine analysis where time, cost effectiveness and high specificity of analytical technique are of great importance.
Highlights
Oxybutynin, solifenacin, tolterodine and fesoterodine as an antimuscarinic/anticholinergic muscle relaxant, used to reduce urinary frequency, urinary urgency and urinary incontinence in people with an overactive bladder
OXB, SOL, TOL and FES reacted with an anionic dye (ECR) in acidic buffer to form ion-pair complexes, which are soluble in dichloromethane
The proposed method characterized by using simple reagents which can be afforded by any ordinary analytical laboratory
Summary
Oxybutynin, solifenacin, tolterodine and fesoterodine as an antimuscarinic/anticholinergic muscle relaxant, used to reduce urinary frequency, urinary urgency and urinary incontinence in people with an overactive bladder. They works by relaxing the involuntary detrusor muscle in the wall of the bladder by blocking muscarinic/cholinergic receptors present on the surface of the muscle cells and prevents acetylcholine from acting on these receptors [1,2,3,4]. Though the chromatographic methods are precise the instrumentations are expensive and required critical experimental conditions These techniques are not applied for routine analysis of SOL. Very few literatures are cited on spectrophotometric methods [28, 29]
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